510(k) K041592 ยท KWP Appliance, Fixation, Spinal Interlaminal
CORAL SPINAL SYSTEM
| Applicant | Theken Surgical, Akron OH, US |
| Decision | Substantially Equivalent, Sep 16, 2004 |
| Received | Jun 14, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041592
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 23, 2005 | Theken Spine LLC Torque Limiting Handle, model # 10-40-0122, a component of the Lumbar Coral System (Pedicle Screw System). Terminated |
LXH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.