TEMA Elbow system - Line extension— 510(k) K222807
Substantially EquivalentLima Corporate S.P.A.
FDA 510(k) clearance K222807 for TEMA Elbow system - Line extension, Substantially Equivalent on 2022-10-26. Applicant: Lima Corporate S.P.A.. Device class: 2.
Clearance details
- Applicant
- Lima Corporate S.P.A.
- Product code
- Code JDB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3160
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Villanova Di San Daniele Del Friuli, IT
Recent devices under product code JDB
view allMore clearances from Lima Corporate S.P.A.
view allAdverse events under product code JDB
product code JDB- Injury
- 352
- Total
- 352
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 →
Recalls naming K222807
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K222807.
Data sourced from openFDA. This site is unofficial and independent of the FDA.