Bsm- Bone Substitute Material
by Etex Corp.
510(k) K983009
Bsm- Bone Substitute Material is a Class II device made by Etex Corp., cleared under FDA 510(k) K983009 on 25 Nov 1998, 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 | NumberK983009 | Date25 Nov 1998 | StatusActive |
Official records
- FDA 510(k) database K983009
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GXP
- Device class
- Class II
- Regulation
- 21 CFR Part 882.5300
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
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