LigaPASS® Spinal System, CD Horizon™ Spinal System
FDA 510(k) clearance K211057 · decided 2021-05-27
Clearance details
- K-number
- K211057
- Device name
- LigaPASS® Spinal System, CD Horizon™ Spinal System
- Applicant
- Medtronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-04-09
- Decision date
- 2021-05-27
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- OWI
- Device class
- 2
- Regulation number
- 888.3010
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Memphis, TN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LigaPASS™ System (K261374) | Medicrea International S.A.S | 2026-05-27 |
| Invictus Bands System (K253615) | Alphatec Spine, Inc. | 2026-03-25 |
| OLYMPIC Deformity Band System (K222097) | Astura Medical | 2023-05-04 |
| HILINE™ Fixation System (K230565) | Globus Medical, Inc. | 2023-04-20 |
| LigaPASS™ 2.0 Ligament Augmentation System (K213659) | Medicrea International SA | 2022-05-24 |
| Mariner Cap System (K201240) | SeaSpine Orthopedics Corporation | 2020-08-05 |
| The Gecko Spinal System (K200281) | Ortho Development Corporation | 2020-03-31 |
| Response BandLoc Spinal Fixation (K200097) | OrthoPediatrics Corp. | 2020-03-16 |
| JAZZ PF (K191217) | Implanet, S.A. | 2019-08-02 |
| Karma® Fixation System (K190289) | Spinal Elements, Inc. | 2019-04-03 |
| NuVasive® VersaTie® System (K190418) | Nu Vasive, Incorporated | 2019-03-21 |
| Spinal Elements Cerclage System (K180728) | Spinal Elements, Inc. | 2018-09-06 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SynchroMed Infusion System; Ascenda Intrathecal Catheters (P860004/S455) | Medtronic, Inc. | 2025-12-22 |
| Activa Deep Brain Stimulation Therapy System; Percept PC BrainSense (P960009/S527) | Medtronic, Inc. | 2025-12-22 |
| Percepta Bipolar CRT-P W1TR01 NKE Percepta Quadripolar CRT-P W4TR01 NKE Serena Bipolar CRT-P W1TR02 NKE Serena Quadripol (P010015/S574) | Medtronic, Inc. | 2025-12-19 |
| SynchroMed Infusion Systems (P860004/S453) | Medtronic, Inc. | 2025-12-19 |
| Activa Deep Brain Stimulation Therapy System, Percept PC; BrainSense (P960009/S526) | Medtronic, Inc. | 2025-12-18 |
| Activa Deep Brain Stimulation Therapy System (P960009/S514) | Medtronic, Inc. | 2025-12-17 |
| Aurora EV-ICD System (P220012/S061) | Medtronic, Inc. | 2025-12-15 |
| Activa Deep Brain Stimulation Therapy System, Percept PC/RC BrainSense (P960009/S524) | Medtronic, Inc. | 2025-12-08 |