ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100)— 510(k) K083161
Substantially EquivalentConmed Linvatec
FDA 510(k) clearance K083161 for ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100), Substantially Equivalent on 2009-03-27. Applicant: Conmed Linvatec. Device class: 2.
Clearance details
- Applicant
- Conmed Linvatec
- Product code
- Code HRX
- Device class
- Class 2
- Regulation
- 21 CFR 888.1100
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Largo, FL, US
Recent devices under product code HRX
view allMore clearances from Conmed Linvatec
view all- K111779 — Y-KNOT ALL-SUTURE ANCHOR MODEL HF13
- K102410 — MATRYX INTERFERENCE SCREW (5.0-6.5MM)
- K102339 — CONMED LINVATEC SEQUENT MENISCAL REPAIR DEVICE
- K101100 — CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503
- K092898 — CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES
Adverse events under product code HRX
product code HRX- Injury
- 623
- Malfunction
- 11,257
- Total
- 11,880
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.