Medical device manufacturer
Alphatec Spine, Inc.
Alphatec Spine, Inc. holds 101 FDA 510(k) clearances across 21 product codes. Median elapsed review time is 84 days. openFDA lists 57 recall records naming the company. FDA publishes it under 6 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 101
- Product codes
- 21
- Median review
- 84 days
- Recall records
- 57
How does FDA spell Alphatec Spine, Inc.?
FDA publishes this company under 6 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 |
|---|---|---|
| ALPHATEC SPINE, INC. | device/registrationlisting | normalised |
| Alphatec Spine | device/510k | normalised |
| Alphatec Spine, Inc. | device/registrationlisting | normalised |
| Alphatec Spine, Inc. | device/510k | normalised |
| Alphatec Spine, Inc. | device/recall | normalised |
| Alphatec Spine, Inc. | device/enforcement | 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 Alphatec Spine, Inc. file in?
21 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 21 | 60 days | |
| NKB | Thoracolumbosacral Pedicle Screw System | 20 | 59 days | |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 9 | 53 days | |
| OLO | Orthopedic Stereotaxic Instrument | 7 | 90 days | |
| MNI | Orthosis, Spinal Pedicle Fixation | 6 | 76 days | |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 5 | 104 days | |
| KWP | Appliance, Fixation, Spinal Interlaminal | 4 | 90 days | |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 4 | 81 days | |
| GWF | Stimulator, Electrical, Evoked Response | 3 | 115 days | |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 3 | 89 days | |
| NKG | Posterior Cervical Screw System | 3 | 44 days | |
| PDQ | Neurosurgical Nerve Locator | 3 | 113 days | |
| MQP | Spinal Vertebral Body Replacement Device | 2 | 70 days | |
| MRW | System, Facet Screw Spinal Device | 2 | 44 days | |
| PHM | Intervertebral Fusion Device With Bone Graft, Thoracic | 2 | 97 days | |
| LLZ | System, Image Processing, Radiological | 1 | 123 days | |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 | 85 days | |
| OWB | Interventional Fluoroscopic X-Ray System | 1 | 118 days | |
| OWI | Bone Fixation Cerclage, Sublaminar | 1 | 127 days | |
| PML | Bone Cement, Posterior Screw Augmentation | 1 | 172 days | |
| SIN | Automated Intraoperative Spinal Rod Bending System | 1 | 269 days |
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 Alphatec Spine, Inc. had a recall?
openFDA lists 57 recall records naming this company across its whole history, of which 3 were opened in the last 12 months and are not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.
Z-2793-2026Class IIOpen, ClassifiedGWF
Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication between the Patient Interface and Tablet, and prompts requiring system reboot; may result in increased operative time and surgical plan change.
Z-1342-2026Class IIOpen, ClassifiedOLO
Due a design issue where the navigated array connection geometry is incorrect.
Z-1343-2026Class IIOpen, ClassifiedOLO
Due a design issue where the navigated array connection geometry is incorrect.
Z-1065-2025Class IIOpen, ClassifiedMAX
Complaints have been received regarding post-operative implant collapse.
Z-1182-2024Class IIOpen, ClassifiedOVD
Due to reports of intraoperative graft bolt implantation breakages.
Showing the 5 most recently initiated of 57.
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 Alphatec Spine, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System | NKB | 88 | |
| K253216 | IntraOp Alignment System; CONTOUR3D Bending System | SIN | 269 | |
| K253615 | Invictus Bands System | OWI | 127 | |
| K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) | OLO | 188 | |
| K252842 | SafeOp 3: Neural Informatix System | GWF | 125 | |
| K251575 | IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody System | OVD | 104 | |
| K251965 | Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) | KWQ | 63 | |
| K251080 | IdentiTi II Cervical Interbody System | ODP | 86 | |
| K243461 | Calibrate Interbody Systems | — | 116 | |
| K241375 | IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer | MAX | 264 |
Source: openFDA device/510k · retrieved
Where is Alphatec Spine, Inc. registered?
FDA lists 3 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 Alphatec Spine, 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.