510(k) K101471 ยท KWP Appliance, Fixation, Spinal Interlaminal
AXLE INTERSPINOUS FUSION SYSTEM
| Applicant | X-Spine Systems, Inc., Miamisburg OH, US |
| Decision | Substantially Equivalent, Nov 24, 2010 |
| Received | May 27, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101471
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 11, 2011 | X Spine Systems Inc Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144
The Axle Torque Dri Terminated |
FZS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.