510(k) K170730
- Device
- JAZZ System, Including JAZZ Band
- Applicant
- Implanet, S.A.
- 510(k) number
- K170730
- Product code
- OWI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-06-09
- Date received
- 2017-03-09
- Regulation
- 888.3010
- Classification name
- Bone Fixation Cerclage, Sublaminar
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Clearance type
- Traditional
- Third party reviewed
- No
Other 510(k) Records For Product Code OWI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253615 | Invictus Bands System | Alphatec Spine, Inc. | 2026-03-25 |
| K222097 | OLYMPIC Deformity Band System | Astura Medical | 2023-05-04 |
| K230565 | HILINE™ Fixation System | Globus Medical, Inc. | 2023-04-20 |
| K213659 | LigaPASS™ 2.0 Ligament Augmentation System | Medicrea International SA | 2022-05-24 |
| K211057 | LigaPASS® Spinal System, CD Horizon™ Spinal System | Medtronic, Inc. | 2021-05-27 |
| K201240 | Mariner Cap System | SeaSpine Orthopedics Corporation | 2020-08-05 |
| K200281 | The Gecko Spinal System | Ortho Development Corporation | 2020-03-31 |
| K200097 | Response BandLoc Spinal Fixation | OrthoPediatrics Corp. | 2020-03-16 |
| K191217 | JAZZ PF | Implanet, S.A. | 2019-08-02 |
| K190289 | Karma® Fixation System | Spinal Elements, Inc. | 2019-04-03 |
| K190418 | NuVasive® VersaTie® System | Nu Vasive, Incorporated | 2019-03-21 |
| K180728 | Spinal Elements Cerclage System | Spinal Elements, Inc. | 2018-09-06 |
| K181799 | ResCUBE™ Ligament Fixation System | Cousin Biotech Sas | 2018-08-29 |
| K172206 | NAJA™ Ligament Correction System | Cousin Biotech Sas | 2018-04-10 |
| K173506 | LigaPASS | Medicrea International SA | 2018-04-03 |
Legacy Summary#
summary
FDA Review#
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