FDA product code · Orthopedic
OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
Product code OVD covers Intervertebral Fusion Device With Integrated Fixation, Lumbar, a Class II device regulated under 21 CFR 888.3080. FDA has cleared 202 devices in this code, 7 of them in the last 12 months. Median review time across the 202 most recent decisions is 112 days. openFDA lists 36 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 888.3080
- Review panel
- Orthopedic
- Clearances
- 202
What is happening in OVD right now?
OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar) has three findings, most consequential first. 2 recalls opened in the last 12 months and not yet terminated (Class II, Class III) (Z-2213-2026, Z-0893-2026). 1 first-time filer in the last 12 months, Tyber Medical (K260810). The code is crowded, scoring 73 of 100 — 87 companies hold a clearance here and 7 arrived in the last 12 months (OVD:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2213-2026, Z-0893-2026 |
| New entrant | Worth knowing | K260810 |
| Crowding | Context | OVD:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
What does product code OVD cover?
OVD is FDA's product code for Intervertebral Fusion Device With Integrated Fixation, Lumbar, a Class II device regulated under 21 CFR 888.3080.
Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
Source: openFDA device/classification · record OVD · retrieved
How many devices has FDA cleared in OVD?
FDA has cleared 202 devices under product code OVD since the 510(k) programme began in 1976, 7 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System | Kyocera Medical Technologies, Inc. | |
| K260810 | Anteralign LS coverplate | Tyber Medical, LLC | |
| K254202 | MectaLIF 3D Metal Anterior | Medacta International S.A. | |
| K253401 | SCRIPT Implant System | Globus Medical, Inc. | |
| K253559 | Ventana A Anterior Lumbar Interbody System | Spinal Elements, Inc. | |
| K251829 | DeGen Medical Patient Specific Implant (PSI) System | Degen Medical | |
| K251575 | IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody System | Alphatec Spine | |
| K250072 | CONDUIT SYNFIX Evolution Secured Spacer System | Avalign Technologies, Inc. | |
| K251644 | ProAM ALIF System | Pro Surgical, Inc. | |
| K250845 | Curiteva Porous PEEK Standalone ALIF System | Curiteva, Inc. |
How long does FDA review take for OVD?
The median FDA review time for OVD is 112 days, measured across the 202 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in OVD?
openFDA lists 36 recall records against product code OVD. A recall record covers one firm's corrective action and may span many device lots.
Z-2213-2026Open, ClassifiedNovapproach Spine, LLC
Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the implant with the inserter, which could lead to procedural delay and/or the need to select an alternative implant.
Z-0893-2026Open, ClassifiedOrthofix U.S. LLC
Labeling contains claims that are not consistently present.
Z-1488-2025Open, ClassifiedStryker Spine
Potential for the gold unlock button to separate from the inserter.
Z-1489-2025Open, ClassifiedStryker Spine
Potential for the gold unlock button to separate from the inserter.
Z-1490-2025Open, ClassifiedStryker Spine
Potential for the gold unlock button to separate from the inserter.
Showing the 5 most recently initiated of 36. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for OVD?
MAUDE holds 199 adverse-event reports naming product code OVD, 36 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in OVD unusual?
Every month with enough history behind it falls inside OVD's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 3 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 15 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 2 | 0–14 | Within expected (0–14) | |
| 2 | 0–11 | Within expected (0–11) | |
| 3 | 0–12 | Within expected (0–12) | |
| 7 | 0–12 | Within expected (0–12) | |
| 6 | 0–12 | Within expected (0–12) | |
| 2 | 0–13 | Within expected (0–13) | |
| 7 | 0–15 | Within expected (0–15) | |
| 2 | 0–11 | Within expected (0–11) | |
| 8 | 0–9 | Within expected (0–9) | |
| 6 | 1–10 | Within expected (1–10) | |
| 2 | 1–9 | Within expected (1–9) | |
| 3 | 0–9 | Within expected (0–9) | |
| 1 | 0–10 | Within expected (0–10) | |
| 7 | 0–8 | Within expected (0–8) | |
| 7 | 0–10 | Within expected (0–10) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in OVD.
Who has entered OVD in the last year?
One company filed in OVD for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Tyber Medical | K260810 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in OVD?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in OVD?
Across the 202 most recent decisions, these applicants filed most often in OVD.
| Applicant | Recent clearances |
|---|---|
| Globus Medical, Inc. | 11 |
| Nu Vasive, Incorporated | 10 |
| K2m, Inc. | 6 |
| Medacta International S.A. | 5 |
| Alphatec Spine, Inc. | 4 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
2 companies in OVD file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| K2M, Inc. | 7 | 2 |
| Alphatec Spine, Inc. | 5 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch OVD
Get an email the morning anything changes in OVD — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.