OWI — Bone Fixation Cerclage, Sublaminar Class II
FDA product code OWI covers "Bone Fixation Cerclage, Sublaminar", a Class II medical device regulated under 21 CFR 888.3010. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OWI
- Device Class
- Class II
- Regulation Number
- 888.3010
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261374 | medicrea international | LigaPASS System | May 27, 2026 |
| K253615 | alphatec spine | Invictus Bands System | March 25, 2026 |
| K222097 | astura medical | OLYMPIC Deformity Band System | May 4, 2023 |
| K230565 | globus medical | HILINE Fixation System | April 20, 2023 |
| K213659 | medicrea international | LigaPASS 2.0 Ligament Augmentation System | May 24, 2022 |
| K211057 | medtronic | LigaPASS® Spinal System, CD Horizon Spinal System | May 27, 2021 |
| K201240 | seaspine orthopedics corporation | Mariner Cap System | August 5, 2020 |
| K200281 | ortho development corporation | The Gecko Spinal System | March 31, 2020 |
| K200097 | orthopediatrics | Response BandLoc Spinal Fixation | March 16, 2020 |
| K191217 | implanet | JAZZ PF | August 2, 2019 |
| K190289 | spinal elements | Karma® Fixation System | April 3, 2019 |
| K190418 | nu vasive, incorporated | NuVasive® VersaTie® System | March 21, 2019 |
| K180728 | spinal elements | Spinal Elements Cerclage System | September 6, 2018 |
| K181799 | cousin biotech | ResCUBE Ligament Fixation System | August 29, 2018 |
| K172206 | cousin biotech | NAJA Ligament Correction System | April 10, 2018 |
| K173506 | medicrea international | LigaPASS | April 3, 2018 |
| K173117 | nuvasive | NuVasive® VersaTie System | December 7, 2017 |
| K172417 | globus medical | SILC® Fixation System | October 26, 2017 |
| K172021 | medicrea international | LigaPASS | August 30, 2017 |
| K171881 | implanet | JAZZ Passer Band | August 8, 2017 |