510(k) K905795 ยท KWH Prosthesis, Toe, Constrained, Polymer
SGARLATO FLEXIBLE HINGE TOE IMPLANT
| Applicant | Sgarlato Laboratories, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, May 29, 1991 |
| Received | Dec 27, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905795
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 4, 2010 | Sgarlato Med, LLC Sgarlato Labs GAIT (Great Toe Implant Technique) Implant-- Large, Product Number 30-100-03 Large, Manufactured by Sgarlato Med LLC, San Jose, CA Terminated |
KWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.