510(k) K050706 ยท GZT Retractor, Self-Retaining, For Neurosurgery
HARMONY PORT SYSTEM, MODEL 1907 SERIES
| Applicant | Spinal Concepts, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Apr 15, 2005 |
| Received | Mar 18, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050706
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 13, 2008 | Abbott Spine Comfort T-Handle Hudson Connector with Impactor Cap; Part #1006-1; handle is component of the following consignment surgical kits: Harmony 2700-0001-PL, Harmony 2700-0009-PL, Harmony 2900-0001-PL, Har Terminated |
GZT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.