FDA Product Code
FDA Product Code OWI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3010
510(k) Clearances — 37 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261374 | LigaPASS System | Medicrea International S.A.S | 2026-05-27 | Special | PDF ↗ |
| K253615 | Invictus Bands System | Alphatec Spine, Inc. | 2026-03-25 | Traditional | PDF ↗ |
| K222097 | OLYMPIC Deformity Band System | Astura Medical | 2023-05-04 | Traditional | PDF ↗ |
| K230565 | HILINE Fixation System | Globus Medical, Inc. | 2023-04-20 | Traditional | PDF ↗ |
| K213659 | LigaPASS 2.0 Ligament Augmentation System | Medicrea International SA | 2022-05-24 | Traditional | PDF ↗ |
| K211057 | LigaPASS® Spinal System, CD Horizon Spinal System | Medtronic, Inc. | 2021-05-27 | Traditional | PDF ↗ |
| K201240 | Mariner Cap System | SeaSpine Orthopedics Corporation | 2020-08-05 | Traditional | PDF ↗ |
| K200281 | The Gecko Spinal System | Ortho Development Corporation | 2020-03-31 | Traditional | PDF ↗ |
| K200097 | Response BandLoc Spinal Fixation | OrthoPediatrics Corp. | 2020-03-16 | Traditional | PDF ↗ |
| K191217 | JAZZ PF | Implanet, S.A. | 2019-08-02 | Traditional | PDF ↗ |
| K190289 | Karma® Fixation System | Spinal Elements, Inc. | 2019-04-03 | Traditional | PDF ↗ |
| K190418 | NuVasive® VersaTie® System | Nu Vasive, Incorporated | 2019-03-21 | Special | PDF ↗ |
| K180728 | Spinal Elements Cerclage System | Spinal Elements, Inc. | 2018-09-06 | Traditional | PDF ↗ |
| K181799 | ResCUBE Ligament Fixation System | Cousin Biotech Sas | 2018-08-29 | Traditional | PDF ↗ |
| K172206 | NAJA Ligament Correction System | Cousin Biotech Sas | 2018-04-10 | Traditional | PDF ↗ |
| K173506 | LigaPASS | Medicrea International SA | 2018-04-03 | Traditional | PDF ↗ |
| K173117 | NuVasive® VersaTie System | Nuvasive, Inc. | 2017-12-07 | Traditional | PDF ↗ |
| K172417 | SILC® Fixation System | Globus Medical, Inc. | 2017-10-26 | Traditional | PDF ↗ |
| K172021 | LigaPASS | Medicrea International SA | 2017-08-30 | Traditional | PDF ↗ |
| K171881 | JAZZ Passer Band | Implanet, S.A. | 2017-08-08 | Traditional | PDF ↗ |
| K170730 | JAZZ System, including JAZZ Band | Implanet, S.A. | 2017-06-09 | Traditional | PDF ↗ |
| K163181 | TRANSLACE Spinal Tethering System | Medtronic Sofamor Danek USA, Inc. | 2017-05-16 | Traditional | PDF ↗ |
| K161332 | NILE Proximal Fixation Spinal System | K2m, Inc. | 2017-04-05 | Traditional | PDF ↗ |
| K160698 | LigaPASS | Medicrea International SA | 2016-09-02 | Traditional | PDF ↗ |
| K161267 | Response BandLoc Spinal Fixation | OrthoPediatrics Corp. | 2016-08-11 | Traditional | PDF ↗ |
| K161265 | NuVasive® VersaTie System | Nu Vasive, Incorporated | 2016-07-15 | Traditional | PDF ↗ |
| K153348 | JAZZ LOCK | Implanet, S.A. | 2016-03-31 | Traditional | PDF ↗ |
| K160208 | NILE Alternative Fixation Spinal System | K2m, Inc. | 2016-03-18 | Special | PDF ↗ |
| K151740 | JAZZ System | Implanet, S.A. | 2015-08-27 | Traditional | PDF ↗ |
| K143759 | JAZZ System | Implanet, S.A. | 2015-05-07 | Traditional | PDF ↗ |
| K143350 | Nile Alternative Fixation | K2m, Inc. | 2015-02-25 | Traditional | PDF ↗ |
| K142053 | UNIVERSAL CLAMP SPINAL FIXATION SYSTEM | Zimmer Spine, Inc. | 2014-10-29 | Traditional | PDF ↗ |
| K133482 | SILC FIXATION SYSTEM | Globus Medical, Inc. | 2014-05-21 | Traditional | PDF ↗ |
| K133617 | JAZZ SYSTEM | Implanet, S.A. | 2014-02-20 | Traditional | PDF ↗ |
| K132395 | LIGAPASS | Medicrea International | 2013-12-06 | Traditional | PDF ↗ |
| K132287 | JAZZ SYSTEM | Hogan Lovells US LLP | 2013-09-25 | Traditional | PDF ↗ |
| K110348 | UNIVERSAL CLAMP SPINAL FIXATION SYSTEM | Zimmer Spine | 2011-08-11 | Traditional | PDF ↗ |
Product code OWI · Class II · Orthopedic. Data: openFDA.