Bsm Bone Substitute Material
510(k) K011048
Bsm Bone Substitute Material is a Class II device made by Depuy Orthopaedics, Inc., cleared under FDA 510(k) K011048 on 13 Nov 2001, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK011048 | Date13 Nov 2001 | StatusActive |
Official records
- FDA 510(k) database K011048
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MQV
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3045
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
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