510(k) K100107 ยท OLO Orthopedic Stereotaxic Instrument
SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0
| Applicant | Smith & Nephew, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Feb 23, 2010 |
| Received | Jan 14, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100107
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2010 | Smith & Nephew Inc smith & nephew TRIGEN SURESHOT Distal Targeting System, Trauma Interface, V2.0.2, Trauma Launcher V1.01.1
Product is intended to be an intraoperative image-guided localization system. It is a computer Terminated |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.