Axya Medical, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Axya Medical, Inc.” (first 1998, latest 2007), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 73 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 |
|---|---|---|---|
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 5 | 5 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 5 | 5 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 3 | 3 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 3 | 3 |
| GAB | Needle, Suturing, Disposable | 1 | 1 |
| JDR | Staple, Fixation, Bone | 1 | 1 |
| LFL | Instrument, Ultrasonic Surgical | 1 | 1 |
Review panels
Most recent Axya Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K070773 | AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHOR | MBI | 2007-10-11 | 204 |
| K070253 | AXYA SUTURE WELDING SYSTEM AND KIT | GAT | 2007-07-11 | 166 |
| K063194 | TUFFLEX POLYESTER SUTURE | GAT | 2006-12-04 | 45 |
| K060165 | AXYAFLEX POLYESTER SUTURE | GAT | 2006-09-01 | 221 |
| K060970 | AXYALOOP NONABSORBABLE BONE ANCHOR | JDR | 2006-07-05 | 89 |
| K052491 | AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR | MBI | 2005-10-07 | 25 |
| K051983 | MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR | MAI | 2005-08-05 | 14 |
| K051250 | AXYA, MODEL 6500 AXYALOOP BIO-ABSORBABLE BONE ANCHOR | MAI | 2005-06-09 | 24 |
| K041698 | AXYA MEDICAL, INC. MODEL 5000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR | MAI | 2004-10-05 | 105 |
| K022207 | AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM | MBI | 2002-10-04 | 88 |
9 earlier clearances. See the full list in Caduvo.
Recalls
25 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2007-09-27.
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 Axya Medical, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Axya Medical, Inc.” (first 1998, latest 2007), across 7 product codes in 2 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 Axya Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Axya Medical, Inc. is 73 days.
Which FDA product codes appear under Axya Medical, Inc.?
The most frequent FDA product codes under this applicant name are GAW (Suture, Nonabsorbable, Synthetic, Polypropylene, 5); MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 5); GAT (Suture, Nonabsorbable, Synthetic, Polyethylene, 3).
Next steps
- See all 19 Axya Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GAW, Axya Medical, 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.