JAZZ System
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK191217 | Date2 Aug 2019 | StatusActive |
| United States | GUDID listing | Number03607503506342 | Date20 Mar 2019 | StatusListed |
Recalls
No FDA recalls found in the data synced 8 Jun 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Trans-facet-screw internal spinal fixation system, sterile
- Model / Ref / Catalog
- Jazz Screw - Polyaxial Screw Dia.7.5 L55, 350634
- Primary DI / UDI-DI
- 03607503506342
- FDA product code
- NKB, OWI
- GMDN term
- Trans-facet-screw internal spinal fixation system, sterile
- Device class
- Class II
- Regulation number
- 888.3070, 888.3010
- GUDID distribution status
- In Commercial Distribution
- Size
- Lumen/Inner Diameter — 7.5 MillimeterLength — 55 Millimeter
Other devices from Implanet
Properties
Other properties (11)
- Sterilise before use: No
- Implantable: No
- Contains latex: No
- Prescription use: No
- Over-the-counter: No
- Convenience kit: No
- Combination product: No
- HCT/P: No
- Premarket exempt: No
- Serial number: No
- Manufacturing date: No