Expedium 186122025
Expedium 186122025 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 10705034105505), 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 | Number10705034105505 | Date24 Sep 2015 | StatusListed |
| United States | FDA 510(k)SESU | NumberK111136 | Date14 Jun 2012 | StatusActive |
Official records
- AccessGUDID record 10705034105505
- FDA 510(k) database K111136
- FDA 510(k) database K081252
Across registries
- FDA 510(k) K111136 decided 14 Jun 2012 Active
- FDA GUDID UDI-DI 10705034105505 listed 24 Sep 2015 Listed
Recalls
-
- Terminated Z-1674-2015
Device does not mate as intended.
Timeline
- Cleared FDA 510(k) K081252
- Cleared FDA 510(k) K111136
- Recall initiated FDA recalls Z-1674-2015
- Listed FDA GUDID 10705034105505
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Expedium
- Generic name
- Spinal bone screw, non-bioabsorbable
- Model / Ref / Catalog
- 186122025
- Primary DI / UDI-DI
- 10705034105505
- FDA product code
- KWQ, NKB, OSH, KWP, MNI, MNH
- GMDN term
- Spinal bone screw, non-bioabsorbable
- Device class
- Class II
- Regulation number
- 888.3060, 888.3070, 888.3050
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Spinal bone screw, non-bioabsorbable.
- Sterile Posterior Spinal Fixation System SR-C221-55080 by Shanghai Reach Medical Instrument Co., Ltd
- KHEIRON 26TC20075 by S.M.A.I.O
- RIALTO™ SI FUSION SYSTEM 74200001255 by MEDTRONIC SOFAMOR DANEK, INC.
- Mecta-C Cervical Plate System 03.70.053 by Medacta International SA
- KHEIRON 24PW65100 by S.M.A.I.O
- AccelFix Spinal Fixation System (Sterile) 8102-6540S by L&K Biomed
- Mecta-C Cervical Plate System 03.70.069 by Medacta International SA
- AccelFix Spinal Fixation System (Sterile) 8103-6550S by L&K Biomed
- GSST-0702-2008-CE(4) by GS Medical Co., Ltd.
- Titanium Rod(NS2) T04715100 by Tianjin Zhengtian Medical Instrument Co., Ltd.