JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector— 510(k) K160226
Substantially EquivalentImplanet, S.A.
FDA 510(k) clearance K160226 for JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector, Substantially Equivalent on 2016-05-18. Applicant: Implanet, S.A.. Device class: 2.
Clearance details
- Applicant
- Implanet, S.A.
- Product code
- Code NKB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Martillac, FR
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More clearances from Implanet, S.A.
view allAdverse events under product code NKB
product code NKB- Death
- 27
- Injury
- 5,033
- Malfunction
- 4,140
- Total
- 9,200
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.