Alphatec/Nexmed: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Alphatec/Nexmed” (first 2004, latest 2005), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 36 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 |
|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | 2 | 2 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 2 | 2 |
| MQP | Spinal Vertebral Body Replacement Device | 2 | 2 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 1 | 1 |
Review panels
- Orthopedic (9)
Most recent Alphatec/Nexmed 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K050830 | ZODIAC SPINAL FIXATION SYSTEM | KWP | 2005-06-22 | 82 |
| K051286 | ZODIAC SPINAL FIXATION SYSTEM | MNH | 2005-06-17 | 30 |
| K050553 | NOVEL VBR SPINAL SYSTEM | MQP | 2005-04-18 | 46 |
| K050390 | TAMARACK ANTERIOR THORACOLUNBAR | KWQ | 2005-03-14 | 26 |
| K050078 | ROC LUMBAR PLATING SYSTEM | MNH | 2005-02-18 | 36 |
| K042252 | NEXFLEX TOTAL HIP SYSTEM | LPH | 2004-12-06 | 108 |
| K042673 | ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM | KWP | 2004-10-27 | 28 |
| K042440 | ALPHATEC FEMORAL TROCHANTERIC NAIL (FTN) SYSTEM | HSB | 2004-10-07 | 28 |
| K042201 | NOVEL VBR SPINAL SYSTEM | MQP | 2004-10-07 | 55 |
Recalls
openFDA lists no recalls under a recalling firm named Alphatec/Nexmed.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Alphatec/Nexmed?
FDA lists 9 510(k) clearances under the applicant name “Alphatec/Nexmed” (first 2004, latest 2005), across 6 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/Nexmed?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alphatec/Nexmed is 36 days.
Which FDA product codes appear under Alphatec/Nexmed?
The most frequent FDA product codes under this applicant name are KWP (Appliance, Fixation, Spinal Interlaminal, 2); MNH (Orthosis, Spondylolisthesis Spinal Fixation, 2); MQP (Spinal Vertebral Body Replacement Device, 2).
Next steps
- See all 9 Alphatec/Nexmed clearances with predicates and recalls
- Run predicate analysis for product code KWP, Alphatec/Nexmed'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.