Alphatec Spine, Inc.: FDA filings under this applicant name
FDA lists 101 510(k) clearances under the applicant name “Alphatec Spine, Inc.” (first 2005, latest 2026), across 22 product codes in 3 review panels. Median 510(k) review time under this name: 84 days. Since 2017 the median was 81 days, against 98 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 135 |
| 2013 | 4 | 57 |
| 2014 | 1 | 146 |
| 2015 | 3 | 83 |
| 2016 | 4 | 145 |
| 2017 | 1 | 16 |
| 2018 | 7 | 60 |
| 2019 | 6 | 74 |
| 2020 | 7 | 59 |
| 2021 | 6 | 78 |
| 2022 | 8 | 90 |
| 2023 | 11 | 74 |
| 2024 | 7 | 59 |
| 2025 | 5 | 104 |
| 2026 | 5 | 127 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Alphatec Spine, Inc. took a median 81 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 98 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 21 | 21 |
| NKB | Thoracolumbosacral Pedicle Screw System | 20 | 20 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 9 | 9 |
| OLO | Orthopedic Stereotaxic Instrument | 7 | 7 |
| MNI | Orthosis, Spinal Pedicle Fixation | 6 | 6 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 5 | 5 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 4 | 4 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 4 | 4 |
| GWF | Stimulator, Electrical, Evoked Response | 3 | 3 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 3 | 3 |
Plus 12 more product codes.
Review panels
- Orthopedic (92)
- Neurology (6)
- Radiology (2)
Most recent Alphatec Spine, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System | NKB | 2026-07-14 | 88 |
| K253216 | IntraOp Alignment System; CONTOUR3D Bending System | SIN | 2026-06-25 | 269 |
| K253615 | Invictus Bands System | OWI | 2026-03-25 | 127 |
| K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) | OLO | 2026-02-19 | 188 |
| K252842 | SafeOp 3: Neural Informatix System | GWF | 2026-01-11 | 125 |
| K251575 | IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody System | OVD | 2025-09-03 | 104 |
| K251965 | Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) | KWQ | 2025-08-28 | 63 |
| K251080 | IdentiTi II Cervical Interbody System | ODP | 2025-07-03 | 86 |
| K243461 | Calibrate Interbody Systems | — | 2025-03-04 | 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 | 2025-02-03 | 264 |
91 earlier clearances. See the full list in Caduvo.
Recalls
57 product recalls in 26 recall events; 7 initiated in the last five years. Most recent: 2026-05-13.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Alphatec Spine, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01613144: OsseoScrew Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate (Completed, started 2012-05)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Alphatec Mfg., Inc. (20 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Alphatec Spine, Inc.?
FDA lists 101 510(k) clearances under the applicant name “Alphatec Spine, Inc.” (first 2005, latest 2026), across 22 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Alphatec Spine, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alphatec Spine, Inc. is 84 days. Since 2017: 81 days, versus 98 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Alphatec Spine, Inc.?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 21); NKB (Thoracolumbosacral Pedicle Screw System, 20); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 9).
Next steps
- See all 101 Alphatec Spine, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MAX, Alphatec Spine, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.