3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System
FDA 510(k) clearance K211712 · decided 2022-02-11
Clearance details
- K-number
- K211712
- Device name
- 3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System
- Applicant
- Orthofix US, LLC
- Decision
- Substantially Equivalent
- Date received
- 2021-06-03
- Decision date
- 2022-02-11
- Days to decision
- 253 days
- Clearance type
- Traditional
- Product code
- KWQ
- Device class
- 2
- Regulation number
- 888.3060
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Lewisville, TX, 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 |
|---|---|---|
| Palisades™ Buttress Plate System (K261309) | Bethesda Medical Devices, LLC | 2026-07-16 |
| ARIES Anterior Cervical Plate Systems (K252776) | ZheJiang Decans Medical Devices Co., Ltd. | 2026-05-14 |
| CastleLoc-P Anterior Cervical Plate System (K261112) | L&K BIOMED Co., Ltd. | 2026-05-06 |
| corra™ cervical plating system (K260570) | Carlsmed, Inc. | 2026-04-22 |
| VyPlate™ Anterior Cervical Plate System (K260697) | Vy Spine, LLC | 2026-03-27 |
| ANTERIS Thoracolumbar Plate System (K260015) | SpineCraft | 2026-03-04 |
| PathLoc Lumbar Plate System (K251940) | L&K BIOMED Co., Ltd. | 2026-03-03 |
| Aster (K254182) | Osteonic Co., Ltd. | 2026-02-26 |
| Lumbar Spine Truss System - Plating Solution (LSTS-PS) (K253201) | 4Web, Inc. | 2026-02-12 |
| aprevo® cervical plating system (K252611) | Carlsmed, Inc. | 2025-12-22 |
| Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) (K251965) | Alphatec Spine, Inc. | 2025-08-28 |
| Resolve Anterior Cervical Plate System (K251436) | Pioneer Surgical Technology, Inc. | 2025-07-11 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| AccelStim (P210035/S003) | Orthofix US, LLC | 2025-03-21 |
| AccelStim (P210035/S002) | Orthofix US, LLC | 2024-07-11 |
| AccelStimTM Bone Growth Stimulator (P210035) | Orthofix US, LLC | 2022-05-03 |