Product code OWI
- Device name
- Bone Fixation Cerclage, Sublaminar
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3010
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 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 |
| K173117 | NuVasive® VersaTie™ System | Nuvasive, Inc. | 2017-12-07 |
| K172417 | SILC® Fixation System | Globus Medical, Inc. | 2017-10-26 |
| K172021 | LigaPASS | Medicrea International SA | 2017-08-30 |
| K171881 | JAZZ Passer Band | Implanet, S.A. | 2017-08-08 |
| K163181 | TRANSLACE™ Spinal Tethering System | Medtronic Sofamor Danek USA, Inc. | 2017-05-16 |
| K161332 | NILE Proximal Fixation Spinal System | K2m, Inc. | 2017-04-05 |
| K160698 | LigaPASS | Medicrea International SA | 2016-09-02 |
| K161267 | Response BandLoc Spinal Fixation | OrthoPediatrics Corp. | 2016-08-11 |
| K161265 | NuVasive® VersaTie System | Nu Vasive, Incorporated | 2016-07-15 |
| K153348 | JAZZ LOCK | Implanet, S.A. | 2016-03-31 |
| K160208 | NILE Alternative Fixation Spinal System | K2m, Inc. | 2016-03-18 |
| K151740 | JAZZ System | Implanet, S.A. | 2015-08-27 |
| K143759 | JAZZ System | Implanet, S.A. | 2015-05-07 |
| K143350 | Nile Alternative Fixation | K2m, Inc. | 2015-02-25 |
| K142053 | UNIVERSAL CLAMP SPINAL FIXATION SYSTEM | Zimmer Spine, Inc. | 2014-10-29 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00190376696157 | Invictus | ALPHATEC SPINE, INC. | 2026-04-09 |
| 00190376696140 | Invictus | ALPHATEC SPINE, INC. | 2026-04-09 |
| 00190376721712 | Invictus | ALPHATEC SPINE, INC. | 2026-04-09 |
| 00190376721705 | Invictus | ALPHATEC SPINE, INC. | 2026-04-09 |
| 00190376721699 | Invictus | ALPHATEC SPINE, INC. | 2026-04-09 |
| 00840085278518 | ALTA | Astura Medical | 2026-02-03 |
| 00840085277603 | ALTA | Astura Medical | 2026-02-02 |
| 00840085278051 | ALTA | Astura Medical | 2026-02-02 |
| 00840085278068 | ALTA | Astura Medical | 2026-02-02 |
| 03607503506182 | JAZZ System | IMPLANET | 2019-03-20 |
| 03607503506175 | JAZZ System | IMPLANET | 2019-03-20 |
| 03607503506168 | JAZZ System | IMPLANET | 2019-03-20 |
| 03607503506151 | JAZZ System | IMPLANET | 2019-03-20 |
| 03607503506144 | JAZZ System | IMPLANET | 2019-03-20 |
| 03607503506137 | JAZZ System | IMPLANET | 2019-03-20 |
| 03607503506120 | JAZZ System | IMPLANET | 2019-03-20 |
| 03607503506113 | JAZZ System | IMPLANET | 2019-03-20 |
| 03607503506106 | JAZZ System | IMPLANET | 2019-03-20 |
| 03607503506090 | JAZZ System | IMPLANET | 2019-03-20 |
| 03607503506083 | JAZZ System | IMPLANET | 2019-03-20 |
| 03607503506076 | JAZZ System | IMPLANET | 2019-03-20 |
| 03607503506069 | JAZZ System | IMPLANET | 2019-03-20 |
| 03607503506052 | JAZZ System | IMPLANET | 2019-03-20 |
| 03607503506045 | JAZZ System | IMPLANET | 2019-03-20 |
| 03607503506038 | JAZZ System | IMPLANET | 2019-03-20 |
| 03607503506021 | JAZZ System | IMPLANET | 2019-03-20 |
| 03607503506014 | JAZZ System | IMPLANET | 2019-03-20 |
| 03607503506007 | JAZZ System | IMPLANET | 2019-03-20 |
| 00889095230253 | SILC | GLOBUS MEDICAL, INC. | 2015-11-07 |
| 03607503501514 | JAZZ System | IMPLANET | 2015-09-23 |