Stryker 2S Spinal System
510(k) K930009
Stryker 2S Spinal System is a Class II device made by Stryker Corp., cleared under FDA 510(k) K930009 on 1 Sep 1994, 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 | NumberK930009 | Date1 Sep 1994 | StatusActive |
Official records
- FDA 510(k) database K930009
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- Withdrawn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).
- ACROMED SACRAL SCREW by Acromed Corp.
- CD HORIZON® Spinal System 55840005540 by MEDTRONIC SOFAMOR DANEK, INC.
- MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM by MEDTRONIC SOFAMOR DANEK, INC.
- ISOLA(TM) SPINE SYSTEM - ILIAC SCREW by Acromed Corp.
- PERLA ® TL TLF-5S C2 00-S by Spineart
- WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEM by WARSAW ORTHOPEDIC, INC.
- coflex-F trial with X-ray marker, Size 12 RDT00012 by Paradigm Spine, LLC
- DANEK PRECISION ROD SET by Danek Medical, Inc.
- MOUNTAINEER 188319324 by MEDOS INTERNATIONAL SARL
- SYNTHES CERVIFIX SYSTEM by Synthes (Usa)