Nexa Orthopedics, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Nexa Orthopedics, Inc.” (first 1997, latest 2007), across 10 product codes in 1 review panel. Median 510(k) review time under this name: 68 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 |
|---|---|---|---|
| KWH | Prosthesis, Toe, Constrained, Polymer | 4 | 4 |
| HWC | Screw, Fixation, Bone | 3 | 3 |
| JDW | Pin, Fixation, Threaded | 2 | 2 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
| JDR | Staple, Fixation, Bone | 1 | 1 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | 1 | 1 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | 1 | 1 |
| KYI | Prosthesis, Wrist, Carpal Trapezium | 1 | 1 |
| MJW | Prosthesis, Subtalar, Plug, Polymer | 1 | 1 |
| MQV | Filler, Bone Void, Calcium Compound | 1 | 1 |
Review panels
- Orthopedic (16)
Most recent Nexa Orthopedics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K072710 | NEXFIX COMPRESSION PIN | JDW | 2007-11-08 | 44 |
| K071147 | NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM | KWT | 2007-07-20 | 87 |
| K070688 | NEXFIX COMPRESSION STAPLE | JDR | 2007-05-18 | 67 |
| K060386 | NEXA CARPO METACARPAL IMPLANT | KYI | 2006-05-10 | 85 |
| K060071 | NEXA COMPRESSION SCREW | HWC | 2006-01-26 | 17 |
| K053408 | NEXA BONE PLATE AND SCREW SYSTEM | HRS | 2005-12-22 | 15 |
| K053394 | NEXA BONE SCREW SYSTEM | HWC | 2005-12-14 | 8 |
| K051740 | TAPERED COMPRESSION PIN | JDW | 2005-09-06 | 70 |
| K051406 | OSTEOCURE RESORBABLE BEAD KIT | MQV | 2005-08-01 | 62 |
| K033046 | SUBTALAR PEG IMPLANT | MJW | 2003-12-23 | 85 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Nexa Orthopedics, Inc..
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.
- Nexa Medical , Ltd. (1 510(k)s)
- Nexa Medical Limited (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nexa Orthopedics, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Nexa Orthopedics, Inc.” (first 1997, latest 2007), 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 Nexa Orthopedics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nexa Orthopedics, Inc. is 68 days.
Which FDA product codes appear under Nexa Orthopedics, Inc.?
The most frequent FDA product codes under this applicant name are KWH (Prosthesis, Toe, Constrained, Polymer, 4); HWC (Screw, Fixation, Bone, 3); JDW (Pin, Fixation, Threaded, 2).
Next steps
- See all 16 Nexa Orthopedics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KWH, Nexa Orthopedics, 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.