LIMACORPORATE SMR CTA HUMERAL HEADS— 510(k) K131112
Substantially EquivalentLima Corporate S.P.A.
FDA 510(k) clearance K131112 for LIMACORPORATE SMR CTA HUMERAL HEADS, Substantially Equivalent on 2013-06-07. Applicant: Lima Corporate S.P.A.. Device class: 2.
Clearance details
- Applicant
- Lima Corporate S.P.A.
- 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
- Winona Lake, IN, US
Recent devices under product code KWS
view allMore clearances from Lima Corporate S.P.A.
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.