Osteoxpress Gd-5515
Osteoxpress Gd-5515, a bone graft delivery kit (FDA Class II; FDA product code FMF, Syringe, Piston) made by Micromedics, Inc., was cleared under FDA 510(k) K151543 on 7 Jul 2015 and listed in FDA GUDID on 13 Jan 2017 (UDI-DI 00815634020467); the registry lists it as not in commercial distribution (GUDID) 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 | GUDID listing | Number00815634020467 | Date13 Jan 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK151543 | Date7 Jul 2015 | StatusActive |
Official records
- AccessGUDID record 00815634020467
- FDA 510(k) database K151543
Across registries
- FDA 510(k) K151543 decided 7 Jul 2015 Active
- FDA GUDID UDI-DI 00815634020467 listed 13 Jan 2017 Listed
Timeline
- Cleared FDA 510(k) K151543
- Listed FDA GUDID 00815634020467
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Osteoxpress
- Generic name
- Bone graft delivery kit
- Model / reference
- GD-5515
- Primary DI / UDI-DI
- 00815634020467
- 510(k) Number
- FDA product code
- FMF
- GMDN term
- Bone graft delivery kit
- Device class
- Class II
- Regulation number
- 880.5860
- GUDID distribution status
- Not in Commercial Distribution
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