Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
The Mesh, Surgical, Absorbable, Plastic and Reconstructive Surgery is an absorbable surgical mesh implant used for reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery procedures. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is OXF, with regulation number 878.3300 under the General, Plastic Surgery medical specialty, and it carries an implant flag.
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Basic Information
- Product Code
- OXF
- Device Class
- FDA class 2
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
Definition
For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K251224 | Restrata Soft Tissue Reinforcement (STR) | Jun 20, 2025 | Substantially Equivalent | Acera Surgical, Inc. |
| K243302 | 3DMatrix DynaFlex (DynaFlex) | May 21, 2025 | Substantially Equivalent | Printbio, Inc. |
| K232602 | 3DMatrix Surgical Mesh | May 23, 2024 | Substantially Equivalent | Printbio, Inc. |
| K222919 | GORE® ENFORM Biomaterial | Dec 19, 2022 | Substantially Equivalent | W. L. Gore and Associates, Inc. |
| K173333 | GORE ENFORM Biomaterial | Apr 05, 2018 | Substantially Equivalent | W. L. Gore & Associates, Inc. |
| K172545 | SERI Contour | Sep 22, 2017 | Substantially Equivalent | Sofregen Medical, Inc. |
| K163217 | GORE BIO-A Tissue Reinforcement | Feb 10, 2017 | Substantially Equivalent | W. L. Gore & Associates, Inc. |
| K123128 | SERI SURGICAL SCAFFOLD | Apr 25, 2013 | Substantially Equivalent | Allergan |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.