JAZZ PF
FDA 510(k) clearance K191217 · decided 2019-08-02
Clearance details
- K-number
- K191217
- Device name
- JAZZ PF
- Applicant
- Implanet, S.A.
- Decision
- Substantially Equivalent
- Date received
- 2019-05-06
- Decision date
- 2019-08-02
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- OWI
- Device class
- 2
- Regulation number
- 888.3010
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Martillac, FR
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Implanet
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LigaPASS™ System (K261374) | Medicrea International S.A.S | 2026-05-27 |
| Invictus Bands System (K253615) | Alphatec Spine, Inc. | 2026-03-25 |
| OLYMPIC Deformity Band System (K222097) | Astura Medical | 2023-05-04 |
| HILINE™ Fixation System (K230565) | Globus Medical, Inc. | 2023-04-20 |
| LigaPASS™ 2.0 Ligament Augmentation System (K213659) | Medicrea International SA | 2022-05-24 |
| LigaPASS® Spinal System, CD Horizon™ Spinal System (K211057) | Medtronic, Inc. | 2021-05-27 |
| Mariner Cap System (K201240) | SeaSpine Orthopedics Corporation | 2020-08-05 |
| The Gecko Spinal System (K200281) | Ortho Development Corporation | 2020-03-31 |
| Response BandLoc Spinal Fixation (K200097) | OrthoPediatrics Corp. | 2020-03-16 |
| Karma® Fixation System (K190289) | Spinal Elements, Inc. | 2019-04-03 |
| NuVasive® VersaTie® System (K190418) | Nu Vasive, Incorporated | 2019-03-21 |
| Spinal Elements Cerclage System (K180728) | Spinal Elements, Inc. | 2018-09-06 |
Recalls involving this device
No recalls on record reference this clearance.