510(k) K050519 ยท GEY Motor, Surgical Instrument, Ac-Powered
ADVANCED TURBO DRIVE SYSTEM
| Applicant | Linvatec Corp., Largo FL, US |
| Decision | Substantially Equivalent, May 17, 2005 |
| Received | Mar 1, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050519
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 6, 2013 | Linvatec Corp. dba ConMed Linvatec D3000 Advantage Drive System, 115v
Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and Terminated |
GEY | None listed |
| Mar 6, 2013 | Linvatec Corp. dba ConMed Linvatec D3000I Advantage Drive System, 230v, surgical instrument motor.
Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perfor Terminated |
GEY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.