Fraxis
510(k) K172096
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK172096 | Date9 Aug 2017 | StatusActive |
Official records
- FDA 510(k) database K172096
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEX
- FDA applicant
- Ilooda Co,., Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
Fraxis is a Suture Anchor (Product Code: GEX) designed for use in orthopaedic and plastic surgery procedures. These devices are intended to secure soft tissue to bone, providing stable fixation for tendons, ligaments, or other anatomical structures during reconstructive or repair surgeries.
The device is supplied as a sterile, single-use product and is intended for use in surgical settings. It is classified under the FDA’s Special 510(k) pathway with a clearance type designated as Substantially Equivalent (SESE). No MRI safety classification or reusable specifications are noted in the regulatory submission.
Devices cleared under K172096
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Fraxis 1.1 Handpiece | Fraxis 1.1 Handpiece | 08800023200898 | — | On the market |
| Fraxis 1.1 Main Unit | Fraxis 1.1 Main Unit | 08800023200881 | — | On the market |
| Fraxis 1.1 Set Package | Fraxis 1.1 Set Package | 08800023200904 | — | On the market |
| Fraxis Handpiece FRX-C1 | FRX-C1 | 08800016903973 | — | On the market |
| Fraxis Main Unit FRX-C1 | FRX-C1 | 08800016903966 | — | On the market |
| Fraxis Set Package FRX-C1 | FRX-C1 | 08800016903959 | — | On the market |
| Fraxis Zoom Handpiece FRX-C1 | FRX-C1 | 08800016903980 | — | On the market |
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