Tigon Medical: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Tigon Medical” (first 2019, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 118 days. Since 2017 the median was 118 days, against 89 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 |
|---|---|---|
| 2019 | 1 | 131 |
| 2020 | 0 | — |
| 2021 | 1 | 118 |
| 2022 | 0 | — |
| 2023 | 1 | 398 |
| 2024 | 2 | 198 |
| 2025 | 1 | 111 |
| 2026 | 1 | 33 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Tigon Medical took a median 118 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 89 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 6 | 6 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
Review panels
- Orthopedic (7)
Most recent Tigon Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260921 | Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line | MBI | 2026-04-21 | 33 |
| K252596 | Tigon Medical Knotless and Dual Javelin All-Suture Anchors | MBI | 2025-12-04 | 111 |
| K242529 | Tigon Medical All-Suture Anchors (ASA) | MBI | 2024-12-20 | 116 |
| K240175 | Tigon Medical Fractures, Instability, and Reconstruction (FIRE) | HWC | 2024-10-29 | 280 |
| K220464 | Tigon Medical Gryphon Anchor Line | MBI | 2023-03-22 | 398 |
| K211049 | Tigon Medical Button System | MBI | 2021-08-04 | 118 |
| K182507 | Tigon Medical Tissue Anchors | MBI | 2019-01-21 | 131 |
Recalls
openFDA lists no recalls under a recalling firm named Tigon Medical.
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 Tigon Medical?
FDA lists 7 510(k) clearances under the applicant name “Tigon Medical” (first 2019, latest 2026), across 2 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 Tigon Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tigon Medical is 118 days. Since 2017: 118 days, versus 89 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Tigon Medical?
The most frequent FDA product codes under this applicant name are MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 6); HWC (Screw, Fixation, Bone, 1).
Next steps
- See all 7 Tigon Medical clearances with predicates and recalls
- Run predicate analysis for product code MBI, Tigon Medical'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.