Expedium 179775480
Expedium 179775480 is a Class II device made by Depuy Spine, Inc., cleared under FDA 510(k) K111136 on 14 Jun 2012 (1 earlier submission) and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 10705034078168), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10705034078168 | Date24 Sep 2015 | StatusListed |
| United States | FDA 510(k)SESU | NumberK111136 | Date14 Jun 2012 | StatusActive |
Official records
- AccessGUDID record 10705034078168
- FDA 510(k) database K111136
- FDA 510(k) database K082942
Across registries
- FDA 510(k) K111136 decided 14 Jun 2012 Active
- FDA GUDID UDI-DI 10705034078168 listed 24 Sep 2015 Listed
Recalls
-
- Terminated Z-1674-2015
Device does not mate as intended.
Timeline
- Cleared FDA 510(k) K082942
- Cleared FDA 510(k) K111136
- Recall initiated FDA recalls Z-1674-2015
- Listed FDA GUDID 10705034078168
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Expedium
- Generic name
- Bone-screw internal spinal fixation system rod
- Model / Ref / Catalog
- 179775480
- Primary DI / UDI-DI
- 10705034078168
- FDA product code
- MNI, NKB, KWQ, KWP, OSH, MNH
- GMDN term
- Bone-screw internal spinal fixation system rod
- Device class
- Class II
- Regulation number
- 888.3070, 888.3060, 888.3050
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Bone-screw internal spinal fixation system rod.