510(k) K171357
- Device
- SurgiMend PRS Meshed, Revize-X
- Applicant
- Integra LifeSciences Corporation (Owner Of TEI Biosciences)
- 510(k) number
- K171357
- Product code
- OXH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-06-07
- Date received
- 2017-05-09
- Regulation
- 878.3300
- Classification name
- Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kavita Amin
- Address
- 7 Elkins St. Boston MA US 02127 02127
FDA Registration Numbers#
- 3004170064
- 1647098
- 1000393132
- 3005920706
- 3005636544
- 3004464325
- 3009504230
- 3008868758
- 3010155661
- 3002924436
- 1047843
- 9680579
- 3010400367
- 3012102437
- 1213643
- 3002719998
- 3005619880
- 2030598
- 3016823837
- 3003418325
- 3010600625
- 2024024
- 2124215
- 3006017180
- 2530154
- 1835959
- 3009882464
- 3016429246
- 3004681519
Source Documents#
Other 510(k) Records For Product Code OXH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251844 | Kerecis SurgiBind (50241) | Kerecis Limited | 2025-07-15 |
| K202430 | Kerecis Reconstruct | Kerecis Limited | 2021-05-02 |
| K160400 | Miromatrix Biological Mesh | Miromatrix Medical, Inc. | 2016-06-08 |
| K150341 | Miromatrix Biological Mesh RS | Miromatrix Medical, Inc. | 2015-05-12 |
Legacy Summary#
summary
FDA Review#
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