Bone Mulch 907320
Bone Mulch 907320 is a Class II device made by Biomet Sports Medicine, cleared under FDA 510(k) K941941 on 2 Feb 1995 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00880304408982), active as of 23 Oct 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 | Number00880304408982 | Date24 Oct 2015 | StatusListed |
| United States | FDA 510(k)SN | NumberK941941 | Date2 Feb 1995 | StatusActive |
Official records
- AccessGUDID record 00880304408982
- FDA 510(k) database K941941
Across registries
- FDA 510(k) K941941 decided 2 Feb 1995 Active
- FDA GUDID UDI-DI 00880304408982 listed 24 Oct 2015 Listed
Recalls
-
- Terminated Z-0779-2010
The screw may not have the hex dimension inside of the head of the screw, which will prevent the device from being implantable. This may cause a delay in the procedure while another screw is obtained.
Timeline
- Cleared FDA 510(k) K941941
- Recall initiated FDA recalls Z-0779-2010
- Listed FDA GUDID 00880304408982
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Bone Mulch
- Generic name
- Ligament bone anchor
- Model / Ref / Catalog
- 907320
- Primary DI / UDI-DI
- 00880304408982
- 510(k) Number
- FDA product code
- HWC
- GMDN term
- Ligament bone anchor
- Device class
- Class II
- Regulation number
- 888.3040
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Ligament bone anchor.