510(k) K981269 ยท HRX Arthroscope
UNIVERSAL DRIVE SYSTEM
| Applicant | Linvatec Corp., Largo FL, US |
| Decision | Substantially Equivalent, Jun 24, 1998 |
| Received | Apr 7, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981269
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2009 | Linvatec Corp. dba ConMed Linvatec PRO5100, PowerPro Battery Modular Handpiece. Drill mode Nominal Speed Range: 0-1250 rpm,
PRO5200, PowerPro Battery Two Trigger Handpiece. Drill mode Nominal Speed Range: 0-1250 rpm,
PRO5250, Power Terminated |
HRX | None listed |
| Oct 1, 2009 | Linvatec Corp. dba ConMed Linvatec PowerProMax PRO5100M Battery Single Trigger,
PowerProMax PRO5200M Battery Two Trigger,
PowerProMax PRO5250M Battery Two-Trigger Standard,
PowerProMax PRO5300M Battery Oscillator,
PowerProMax PRO54 Terminated |
HRX | None listed |
| Oct 1, 2009 | Linvatec Corp. dba ConMed Linvatec Mpower PRO6200 Single Trigger Modular Handpiece,
Mpower PRO6202 Battery Two-Trigger Modular Handpiece,
Mpower PRO6300 Battery Oscillating Saw,
Mpower PRO6400 Battery Reciprocating Saw, and
Mpowe Terminated |
HRX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.