A-Bsm Bone Substitute Material
by Etex Corp.
510(k) K072636
A-Bsm Bone Substitute Material is a Class II device made by Etex Corp., cleared under FDA 510(k) K072636 on 23 Oct 2007, 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 | NumberK072636 | Date23 Oct 2007 | StatusActive |
Official records
- FDA 510(k) database K072636
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- Withdrawn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
Similar devices
Other devices filed under FDA product code MQV (Filler, Bone Void, Calcium Compound).
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- Adaptos®Fuse Bone Graft by Biomendex OY
- SKAFFOLD NMX BONE VOID FILLER by SKELETAL KINETICS LLC
- MASTERGRAFT STRIP by MEDTRONIC SOFAMOR DANEK, INC.