JAZZ System
JAZZ System (550313) is a Class II device made by Implanet, cleared under FDA 510(k) K191217 on 2 Aug 2019 (5 earlier submissions) and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 03607505503134), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK191217 | Date2 Aug 2019 | StatusActive |
| United States | GUDID listing | Number03607505503134 | Date24 Sep 2015 | StatusListed |
Official records
- AccessGUDID record 03607505503134
- FDA 510(k) database K191217
- FDA 510(k) database K182771
- FDA 510(k) database K171881
- FDA 510(k) database K170730
- FDA 510(k) database K160226
- FDA 510(k) database K151740
Across registries
- FDA 510(k) K191217 decided 2 Aug 2019 Active
- FDA GUDID UDI-DI 03607505503134 listed 24 Sep 2015 Listed
Timeline
- Cleared FDA 510(k) K151740
- Listed FDA GUDID 03607505503134
- Cleared FDA 510(k) K160226
- Cleared FDA 510(k) K170730
- Cleared FDA 510(k) K171881
- Cleared FDA 510(k) K182771
- Cleared FDA 510(k) K191217
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Internal spinal fixation system cable tensioner
- Model / Ref / Catalog
- Tensioner Gen. II - 120° Low Profile Stem, 550313
- Primary DI / UDI-DI
- 03607505503134
- FDA product code
- OWI
- GMDN term
- Internal spinal fixation system cable tensioner
- Device class
- Class II
- Regulation number
- 888.3010
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- Size
- Angle — 120 degree
Similar devices
Other devices filed under FDA product code OWI (Bone Fixation Cerclage, Sublaminar).
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- LigaPASS by Medicrea International SA
- ResCUBE™ Ligament Fixation System by Cousin Biotech Sas
- JAZZ LOCK by Implanet, S.A.
- Invictus Bands System by ALPHATEC SPINE, INC.
- UNIVERSAL CLAMP SPINAL FIXATION SYSTEM by ZIMMER SPINE, INC.