510(k) K033517 ยท MQP Spinal Vertebral Body Replacement Device
SPINAL CONCEPTS INC. CADENCE AND TRAXIS
| Applicant | Spinal Concepts, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Feb 18, 2004 |
| Received | Nov 7, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033517
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2004 | Spinal Concepts, Inc Harmony MIS Life Instruments, Lumbar Spacer Systems manufactured by Spinal Concepts, Austin, Texas. Part numbers 2851-1-01, 2851-1-30, 2851-2-01, 2851-2-30, 2851-3-01, 2851-3-30, 2851-4-01, 2851-4-30 Terminated |
MQP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.