510(k) K121541
K121541 is an FDA 510(k) premarket notification submitted by Implanet, S.A. for the device "JAZZ SYSTEM". The FDA issued a decision of Substantially Equivalent on September 13, 2012. The device falls under product code JDQ (Cerclage, Fixation), a Class II device regulated under 21 CFR 888.3010. Implanet, S.A. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 13, 2012
- Date Received
- May 24, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cerclage, Fixation
- Device Class
- Class II
- Regulation Number
- 888.3010
- Review Panel
- OR
- Submission Type