510(k) K112757 ยท KWP Appliance, Fixation, Spinal Interlaminal
PIONEER POSTERIOR CERVICO THORACIC SYSTEM
| Applicant | Pioneer Surgical Technology, Inc., Marquette MI, US |
| Decision | Substantially Equivalent, Mar 12, 2012 |
| Received | Sep 22, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112757
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 3, 2014 | PIONEER SURGICAL TECHNOLOGY, INC. STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW
REF 26-SETSCREW
NON-STERILE, SINGLE USE, RX ONLY Terminated |
KWP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.