LigaPASS
FDA 510(k) K173506 · Medicrea International SA
510(k) numberK173506
Submission
- Device name
- LigaPASS
- Applicant
- Medicrea International SA
Rillieux-La-Pape, FR - Received
- November 13, 2017
- Decision date
- April 3, 2018
- 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.
Other 510(k)s with product code OWI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K191217 | Jazz PFOWI · Traditional | Implanet, S.A. | 08/02/2019SE |
More from Implanet, S.A.
| 510(k) | Device | Decision |
|---|---|---|
| K213659 | LigaPASS 2.0 Ligament Augmentation SystemOWI · Traditional | 05/24/2022SE |
| K220810 | Infinity OCT System and PASS OCT Spinal SystemNKG · Special | 04/19/2022SE |
| K220724 | CD Horizon Spinal System and PASS LP Spinal SystemNKB · Special | 04/08/2022SE |
| K212005 | UNiD Spine AnalyzerLLZ · Traditional | 01/12/2022SE |
| K213281 | PASS LP Spinal System, CD Horizon Spinal SystemNKB · Traditional | 01/05/2022SE |
| K210470 | C-CURVE Interbody Fusion DeviceOVE · Traditional | 09/03/2021SE |
| K200316 | UNiD IB3D ALIFMAX · Traditional | 10/30/2020SE |
| K191134 | IB3D AlifMAX · Traditional | 10/30/2019SE |
| K182158 | UNiD Patient-matched PLIF cageMAX · Traditional | 07/15/2019SE |
| K190092 | UNiD Patient specific 3D printed TLIF cageMAX · Traditional | 05/08/2019SE |
Questions and answers
When was LigaPASS cleared by the FDA?
LigaPASS (K173506) received a 510(k) decision of Substantially Equivalent on April 3, 2018, 141 days after the submission was received.
What is the product code of K173506?
The FDA product code is OWI – Bone Fixation Cerclage, Sublaminar, a Class II (moderate risk) device regulated under 21 CFR 888.3010.