Integra® MemoFix® MS101513
by Ascension Orthopedics, Inc.
Integra® MemoFix® MS101513 is a Class II device made by Ascension Orthopedics, Inc., cleared under FDA 510(k) K123926 on 3 May 2013 and listed in FDA GUDID since 9 Oct 2017 (UDI-DI 10381780121367), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10381780121367 | Date9 Oct 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK123926 | Date3 May 2013 | StatusActive |
Official records
- AccessGUDID record 10381780121367
- FDA 510(k) database K123926
Across registries
- FDA 510(k) K123926 decided 3 May 2013 Active
- FDA GUDID UDI-DI 10381780121367 listed 9 Oct 2017 Listed
Timeline
- Cleared FDA 510(k) K123926
- Listed FDA GUDID 10381780121367
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Integra® MemoFix®
- Generic name
- Orthopaedic bone staple, non-adjustable
- Model / Ref / Catalog
- MS101513
- Primary DI / UDI-DI
- 10381780121367
- 510(k) Number
- FDA product code
- JDR
- GMDN term
- Orthopaedic bone staple, non-adjustable
- Device class
- Class II
- Regulation number
- 888.3030
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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