710.111.97S
by Synthes GmbH
710.111.97S (71011197S) is a Class II device made by Synthes GmbH, cleared under FDA 510(k) K051720 on 25 Jul 2005 and listed in FDA GUDID since 30 Jun 2016 (UDI-DI 10886982255785), active as of 12 Nov 2026. One FDA recall is 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 | Number10886982255785 | Date30 Jun 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK051720 | Date25 Jul 2005 | StatusActive |
Official records
- AccessGUDID record 10886982255785
- FDA 510(k) database K051720
Across registries
- FDA 510(k) K051720 decided 25 Jul 2005 Active
- FDA GUDID UDI-DI 10886982255785 listed 30 Jun 2016 Listed
Recalls
-
- Terminated Z-3273-2011
Firm became aware that some systems were released to stock without going through the sterilization process.
Timeline
- Cleared FDA 510(k) K051720
- Recall initiated FDA recalls Z-3273-2011
- Listed FDA GUDID 10886982255785
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Bone graft delivery kit
- Model / Ref / Catalog
- 710.111.97S, 71011197S
- Primary DI / UDI-DI
- 10886982255785
- 510(k) Number
- FDA product code
- FMF
- GMDN term
- Bone graft delivery kit
- Device class
- Class II
- Regulation number
- 880.5860
- GUDID distribution status
- In Commercial Distribution
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