OXF — Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery Class II
FDA product code OXF covers "Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery", a Class II medical device regulated under 21 CFR 878.3300. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 8 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OXF
- Device Class
- Class II
- Regulation Number
- 878.3300
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Definition
For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251224 | acera surgical | Restrata Soft Tissue Reinforcement (STR) | June 20, 2025 |
| K243302 | printbio | 3DMatrix DynaFlex (DynaFlex) | May 21, 2025 |
| K232602 | printbio | 3DMatrix Surgical Mesh | May 23, 2024 |
| K222919 | w. l. gore and associates | GORE® ENFORM Biomaterial | December 19, 2022 |
| K173333 | w. l. gore and associates | GORE ENFORM Biomaterial | April 5, 2018 |
| K172545 | sofregen medical | SERI Contour | September 22, 2017 |
| K163217 | w. l. gore and associates | GORE BIO-A Tissue Reinforcement | February 10, 2017 |
| K123128 | allergan | SERI SURGICAL SCAFFOLD | April 25, 2013 |