HALLMARKTM ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k) clearance K050892 · decided 2005-05-11
Clearance details
- K-number
- K050892
- Device name
- HALLMARKTM ANTERIOR CERVICAL PLATE SYSTEM
- Applicant
- Blackstone Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-04-08
- Decision date
- 2005-05-11
- Days to decision
- 33 days
- Clearance type
- Special
- Product code
- KWQ
- Device class
- 2
- Regulation number
- 888.3060
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Springfield, MA, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
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| 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 |
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| 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
| Record | Firm | Date |
|---|---|---|
| Blackstone Medical Inc./ Orthofix Spinal Implants, Hallmark Anterior Cervical Plate System recall (Z-1653-2010) | Blackstone Medical, Inc. | 2010-05-26 |
| Hallmark Anterior Cervical Plate System: Primary Bone Screw, Semi Constrained, REF # 62-31 recall (Z-0478-2008) | Blackstone Medical, Inc. | 2008-01-26 |