JAZZ System Round Passer
JAZZ System Round Passer (550344) is a Class II device made by Implanet, listed in FDA GUDID since 13 Oct 2017 (UDI-DI 03607505503448), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number03607505503448 | Date13 Oct 2017 | StatusListed |
Official records
- AccessGUDID record 03607505503448
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- JAZZ System
- Generic name
- Internal spinal fixation system cable tensioner
- Model / Ref / Catalog
- Round Passer, 550344
- Primary DI / UDI-DI
- 03607505503448
- 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
Similar devices
Other devices filed under FDA product code OWI (Bone Fixation Cerclage, Sublaminar).
- Spinal Elements Cerclage System by SPINAL ELEMENTS, INC.
- NuVasive VersaTie System by Nu Vasive, Incorporated
- LigaPASS by Medicrea International SA
- JAZZ System by Implanet, S.A.
- JAZZ System, including JAZZ Band by Implanet, S.A.
- NILE Proximal Fixation Spinal System by K2M, INC.
- NAJA™ Ligament Correction System by Cousin Biotech Sas
- LigaPASS™ 2.0 Ligament Augmentation System by Medicrea International SA
- OLYMPIC Deformity Band System by Astura Medical
- NuVasive® VersaTie™ System by Nuvasive, Inc.