Jazz PF
FDA 510(k) K191217 · Implanet, S.A.
510(k) numberK191217
Submission
- Device name
- Jazz PF
- Applicant
- Implanet, S.A.
Martillac, FR - Received
- May 6, 2019
- Decision date
- August 2, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OWI – Bone Fixation Cerclage, Sublaminar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3010
- Specialty
- Orthopedic
- Implant
- Yes
Acts as a bone anchor for temporary stabilization, or used in conjunction with other medical implants of similar metals when wiring is needed, during development of a spinal fusion.
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|---|---|---|---|
| K261374 | LigaPASS SystemOWI · Special | Medicrea International S.A.S | 05/27/2026SE |
| K253615 | Invictus Bands SystemOWI · Traditional | Alphatec Spine, Inc. | 03/25/2026SE |
| K222097 | OLYMPIC Deformity Band SystemOWI · Traditional | Astura Medical | 05/04/2023SE |
| K230565 | HILINE Fixation SystemOWI · Traditional | Globus Medical, Inc. | 04/20/2023SE |
| K213659 | LigaPASS 2.0 Ligament Augmentation SystemOWI · Traditional | Medicrea International SA | 05/24/2022SE |
| K211057 | LigaPASS® Spinal System, CD Horizon Spinal SystemOWI · Traditional | Medtronic, Inc. | 05/27/2021SE |
| K201240 | Mariner Cap SystemOWI · Traditional | SeaSpine Orthopedics Corporation | 08/05/2020SE |
| K200281 | The Gecko Spinal SystemOWI · Traditional | Ortho Development Corporation | 03/31/2020SE |
| K200097 | Response BandLoc Spinal FixationOWI · Traditional | OrthoPediatrics Corp. | 03/16/2020SE |
| K190289 | Karma® Fixation SystemOWI · Traditional | Spinal Elements, Inc. | 04/03/2019SE |
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| K230026 | SqualeODP · Traditional | 03/28/2023SE |
| K192084 | Madison Total Knee SystemJWH · Traditional | 10/22/2019SE |
| K182771 | ISS-JAZZ Screw System and JAZZ CAP SPNKB · Traditional | 03/12/2019SE |
| K171881 | JAZZ Passer BandOWI · Traditional | 08/08/2017SE |
| K170730 | JAZZ System, including JAZZ BandOWI · Traditional | 06/09/2017SE |
| K162764 | Jazz Frame SystemNKB · Traditional | 01/19/2017SE |
| K160226 | JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorNKB · Traditional | 05/18/2016SE |
| K153348 | Jazz LockOWI · Traditional | 03/31/2016SE |
| K151740 | JAZZ SystemOWI · Traditional | 08/27/2015SE |
| K143759 | JAZZ SystemOWI · Traditional | 05/07/2015SE |
Questions and answers
When was Jazz PF cleared by the FDA?
Jazz PF (K191217) received a 510(k) decision of Substantially Equivalent on August 2, 2019, 88 days after the submission was received.
What is the product code of K191217?
The FDA product code is OWI – Bone Fixation Cerclage, Sublaminar, a Class II (moderate risk) device regulated under 21 CFR 888.3010.