Medpor 9531
Medpor 9531 is a Class II device made by Stryker Leibinger, cleared under FDA 510(k) K952677 on 21 Aug 1995 and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 07613252086086), active as of 23 Oct 2026. 2 FDA recalls are linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07613252086086 | Date24 Sep 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK952677 | Date21 Aug 1995 | StatusActive |
Official records
- AccessGUDID record 07613252086086
- FDA 510(k) database K952677
Across registries
- FDA 510(k) K952677 decided 21 Aug 1995 Active
- FDA GUDID UDI-DI 07613252086086 listed 24 Sep 2015 Listed
Recalls
-
- Terminated Z-1092-2015
- Terminated Z-1091-2015
Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion intra-operatively, implant damage, implant cracking off/breaking intra-operatively.
Timeline
- Cleared FDA 510(k) K952677
- Recall initiated FDA recalls Z-1092-2015
- Recall initiated FDA recalls Z-1091-2015
- Listed FDA GUDID 07613252086086
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Medpor
- Generic name
- Polyethylene craniofacial tissue reconstructive material
- Model / Ref / Catalog
- 9531
- Primary DI / UDI-DI
- 07613252086086
- 510(k) Number
- FDA product code
- FWP
- GMDN term
- Polyethylene craniofacial tissue reconstructive material
- Device class
- Class II
- Regulation number
- 878.3550
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 52.0 MillimeterWidth — 40.0 Millimeter