TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+— 510(k) K123982
Substantially EquivalentEncore Medical L.P.
FDA 510(k) clearance K123982 for TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+, Substantially Equivalent on 2013-01-23. Applicant: Encore Medical L.P.. Device class: 2.
Clearance details
- Applicant
- Encore Medical L.P.
- Product code
- Code KWS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3660
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Austin, TX, US
Recent devices under product code KWS
view allMore clearances from Encore Medical L.P.
view allAdverse events under product code KWS
product code KWS- Death
- 6
- Injury
- 9,652
- Malfunction
- 1,385
- Other
- 1
- Total
- 11,044
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.