Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
The Mesh, Surgical, Collagen, Plastic and Reconstructive Surgery is a collagen-based 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 OXH, 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
- OXH
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K251844 | Kerecis SurgiBind (50241) | Jul 15, 2025 | Substantially Equivalent | Kerecis Limited |
| K202430 | Kerecis Reconstruct | May 02, 2021 | Substantially Equivalent | Kerecis Limited |
| K171357 | SurgiMend PRS Meshed, Revize-X | Jun 07, 2017 | Substantially Equivalent | Integra Lifesciences Corporation (Owner of Tei Biosciences) |
| K160400 | Miromatrix Biological Mesh | Jun 08, 2016 | Substantially Equivalent | Miromatrix Medical, Inc. |
| K150341 | Miromatrix Biological Mesh RS | May 12, 2015 | Substantially Equivalent | Miromatrix Medical, Inc. |
FEI Numbers
This FDA classification entry is associated with 29 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 29 registration numbers. Click on an entry to view related FDA registrations.