510(k) K041167 ยท NKB Thoracolumbosacral Pedicle Screw System
PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM
| Applicant | Pioneer Surgical Technology, Marquette MI, US |
| Decision | Substantially Equivalent, Jul 23, 2004 |
| Received | May 4, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041167
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 7, 2005 | Pioneer Surgical Technology Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40. Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.