Alphatec Mfg., Inc.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Alphatec Mfg., Inc.” (first 1990, latest 2004), across 10 product codes in 1 review panel. Median 510(k) review time under this name: 132 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 4 | 4 |
| HWC | Screw, Fixation, Bone | 4 | 4 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 3 | 3 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 3 | 3 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 | 1 |
| JDW | Pin, Fixation, Threaded | 1 | 1 |
| JEC | Component, Traction, Invasive | 1 | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 1 | 1 |
| MNI | Orthosis, Spinal Pedicle Fixation | 1 | 1 |
Review panels
- Orthopedic (20)
Most recent Alphatec Mfg., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K033090 | ICON POLYAXIAL PEDICLE SCREW SYSTEM | KWP | 2004-03-26 | 179 |
| K023299 | ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM | MNI | 2002-12-11 | 69 |
| K020356 | ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM | MNH | 2002-07-23 | 169 |
| K993513 | DELTALOC ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2000-04-26 | 191 |
| K993873 | ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD | KTT | 2000-01-03 | 49 |
| K992350 | PYLON INTRAMEDULLAARY NAIL SYSTEM | HSB | 1999-09-22 | 70 |
| K980788 | ALPHATEC WIRE EXTERNAL FIXATION SYSTEM | JDW | 1998-05-22 | 81 |
| K964400 | ALPHATEC EXTERNAL FIXATION SYSTEM | KTT | 1997-04-28 | 175 |
| K951846 | MIRAGE SPINAL SYSTEM FOR SEVERE SPONDYLOLISTHESIS | KWP | 1996-02-14 | 300 |
| K926417 | ALPHATEC 130-150 SLOTTED COMPRESSION HIP SCREW | KTT | 1994-09-28 | 644 |
10 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2002-05-30.
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.
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 Spine, Inc. (101 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Alphatec Mfg., Inc.?
FDA lists 20 510(k) clearances under the applicant name “Alphatec Mfg., Inc.” (first 1990, latest 2004), across 10 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Alphatec Mfg., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alphatec Mfg., Inc. is 132 days.
Which FDA product codes appear under Alphatec Mfg., Inc.?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 4); HWC (Screw, Fixation, Bone, 4); KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, 3).
Next steps
- See all 20 Alphatec Mfg., Inc. clearances with predicates and recalls
- Run predicate analysis for product code HRS, Alphatec Mfg., 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.