Ossifuse Bone Substitute Material
by Etex Corp.
510(k) K072355
Ossifuse Bone Substitute Material is a Class II device made by Etex Corp., cleared under FDA 510(k) K072355 on 26 Sep 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 | NumberK072355 | Date26 Sep 2007 | StatusActive |
Official records
- FDA 510(k) database K072355
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- Withdrawn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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