Miromatrix Biological Mesh RS
FDA 510(k) clearance K150341 · decided 2015-05-12
Clearance details
- K-number
- K150341
- Device name
- Miromatrix Biological Mesh RS
- Applicant
- Miromatrix Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-02-11
- Decision date
- 2015-05-12
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- OXH
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Eden Prairie, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Kerecis SurgiBind (50241) (K251844) | Kerecis Limited | 2025-07-15 |
| Kerecis Reconstruct (K202430) | Kerecis Limited | 2021-05-02 |
| SurgiMend PRS Meshed, Revize-X (K171357) | Integra Lifesciences Corporation (Owner of Tei Biosciences) | 2017-06-07 |
| Miromatrix Biological Mesh (K160400) | Miromatrix Medical, Inc. | 2016-06-08 |
Recalls involving this device
No recalls on record reference this clearance.