ST360 Spinal Fixation System
510(k) K041925
ST360 Spinal Fixation System is a Class II device made by Zimmer Spine, Inc., cleared under FDA 510(k) K041925 on 24 Sep 2004, active as of 22 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 | FDA 510(k)SESE | NumberK041925 | Date24 Sep 2004 | StatusActive |
Official records
- FDA 510(k) database K041925
Recalls
-
- Terminated Z-0190-2007
Zimmer Spine, Inc. is conducting a RECALL of all manufacturing lots of ST360 Distal Thread Reduction Guide Pins due to an issue with the thread timing.
Timeline
- Cleared FDA 510(k) K041925
- Recall initiated FDA recalls Z-0190-2007
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KWP
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3050
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code KWP (Appliance, Fixation, Spinal Interlaminal).
- CD HORIZON® Spinal System G5932004747 by MEDTRONIC SOFAMOR DANEK, INC.
- MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEM by INTELLIGENT IMPLANT SYSTEMS, LLC
- ORIA SPINAL CLIP SYSTEM EXTENDED OMNIAXIAL CONNECTORS (CO05 & CO07) by Ortho Tec, LLC
- PERLA ® TL TLF-MH PL 00-S by Spineart
- DEPUY SEGMENTALSPINAL SYSTEM by Depuy, Inc.
- DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM by Depuy, Inc.
- PERLA ® CPF-PR C0 60-S by Spineart
- NEXTGEN ALTIUS OCT SYSTEM by Biomet Spine (Aka Ebi, LLC)
- Reliance Posterior Cervical-Thoracic System by Reliance Medical Systems, LLC
- OASYS System by Stryker Corp.