OXH — Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery Class II
Classification Details
- Product Code
- OXH
- 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 |
|---|---|---|---|
| K251844 | kerecis limited | Kerecis SurgiBind (50241) | July 15, 2025 |
| K202430 | kerecis limited | Kerecis Reconstruct | May 2, 2021 |
| K171357 | integra lifesciences corporation (owner of tei biosciences) | SurgiMend PRS Meshed, Revize-X | June 7, 2017 |
| K160400 | miromatrix medical | Miromatrix Biological Mesh | June 8, 2016 |
| K150341 | miromatrix medical | Miromatrix Biological Mesh RS | May 12, 2015 |