Solustaple 114004ND
by Newdeal Sas
Solustaple 114004ND is a Class II device made by Newdeal Sas, cleared under FDA 510(k) K991566 on 3 Aug 1999 and listed in FDA GUDID since 9 Oct 2017 (UDI-DI 10381780052388), 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 | Number10381780052388 | Date9 Oct 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK991566 | Date3 Aug 1999 | StatusActive |
Official records
- AccessGUDID record 10381780052388
- FDA 510(k) database K991566
Across registries
- FDA 510(k) K991566 decided 3 Aug 1999 Active
- FDA GUDID UDI-DI 10381780052388 listed 9 Oct 2017 Listed
Timeline
- Cleared FDA 510(k) K991566
- Listed FDA GUDID 10381780052388
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Solustaple
- Generic name
- Orthopaedic bone staple, non-adjustable
- Model / Ref / Catalog
- 114004ND
- Primary DI / UDI-DI
- 10381780052388
- 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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