Medical device manufacturer
Medtronic Sofamor Danek USA, Inc
Medtronic Sofamor Danek USA, Inc holds 184 FDA 510(k) clearances across 29 product codes. Median elapsed review time is 83 days. openFDA lists 172 recall records naming the company. FDA publishes it under 8 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 184
- Product codes
- 29
- Median review
- 83 days
- Recall records
- 172
How does FDA spell Medtronic Sofamor Danek USA, Inc?
FDA publishes this company under 8 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| MEDTRONIC SOFAMOR DANEK USA, INC. | device/registrationlisting | normalised |
| Medtronic Sofamor Danek USA | device/510k | normalised |
| Medtronic Sofamor Danek USA Inc | device/enforcement | normalised |
| Medtronic Sofamor Danek USA Inc | device/recall | normalised |
| Medtronic Sofamor Danek USA, Inc | device/recall | normalised |
| Medtronic Sofamor Danek USA, Inc | device/enforcement | normalised |
| Medtronic Sofamor Danek USA, Inc. | device/510k | normalised |
| Medtronic Sofamor Danek USA, Incorporated | device/510k | normalised |
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, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Medtronic Sofamor Danek USA, Inc file in?
29 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 48 | 58 days | |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 37 | 104 days | |
| OLO | Orthopedic Stereotaxic Instrument | 15 | 55 days | |
| KWP | Appliance, Fixation, Spinal Interlaminal | 10 | 88 days | |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 9 | 71 days | |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 8 | 110 days | |
| NKG | Posterior Cervical Screw System | 7 | 30 days | |
| MQP | Spinal Vertebral Body Replacement Device | 6 | 89 days | |
| MQV | Filler, Bone Void, Calcium Compound | 5 | 105 days | |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 3 | 125 days | |
| JEY | Plate, Bone | 3 | 121 days | |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 3 | 163 days | |
| LYC | Bone Grafting Material, Synthetic | 3 | 116 days | |
| NQP | Posterior Metal/Polymer Spinal System, Fusion | 3 | 81 days | |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 3 | 92 days | |
| PGM | Growing Rod System | 3 | 67 days | |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | 2 | 27 days | |
| JDK | Prosthesis, Hip, Cement Restrictor | 2 | 84 days | |
| MNI | Orthosis, Spinal Pedicle Fixation | 2 | 28 days | |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 2 | 174 days | |
| PML | Bone Cement, Posterior Screw Augmentation | 2 | 117 days | |
| FMF | Syringe, Piston | 1 | 70 days | |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 1 | 63 days | |
| LLZ | System, Image Processing, Radiological | 1 | 247 days | |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 1 | 26 days |
Showing the 25 they file in most, of 29.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Medtronic Sofamor Danek USA, Inc had a recall?
openFDA lists 172 recall records naming this company across its whole history, of which 1 was opened in the last 12 months and is not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.
Z-0580-2026Class IIOpen, ClassifiedMAX
Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur.
Z-0161-2024Class IIOpen, ClassifiedMBP
Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
Z-0162-2024Class IIOpen, ClassifiedMBP
Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
Z-0163-2024Class IIOpen, ClassifiedMBP
Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
Z-0164-2024Class IIOpen, ClassifiedMBP
Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
Showing the 5 most recently initiated of 172.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Medtronic Sofamor Danek USA, Inc cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K253011 | Catalyft PL Expandable Interbody System | MAX | 301 | |
| K261020 | Symmetrix L Spinal System | MAX | 109 | |
| K253656 | OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System | GEI | 197 | |
| K260216 | CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System | NKB | 88 | |
| K254165 | Infinity OCT System | NKG | 30 | |
| K253941 | CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly) | NKB | 29 | |
| K253335 | CD Horizon Spinal System | NKB | 24 | |
| K253129 | Infinity OCT System | NKG | 29 | |
| K251444 | Endoskeleton Interbody Systems | MAX | 118 | |
| K251395 | The Rialto SI Fusion System | OUR | 52 |
Source: openFDA device/510k · retrieved
Where is Medtronic Sofamor Danek USA, Inc registered?
FDA lists 2 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Medtronic Sofamor Danek USA, Inc files next
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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.