ATLANTIS VISION ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k) clearance K021461 · decided 2002-07-22
Clearance details
- K-number
- K021461
- Device name
- ATLANTIS VISION ANTERIOR CERVICAL PLATE SYSTEM
- Applicant
- Medtronic Sofamor Danek
- Decision
- Substantially Equivalent
- Date received
- 2002-05-07
- Decision date
- 2002-07-22
- Days to decision
- 76 days
- Clearance type
- Special
- Product code
- KWQ
- Device class
- 2
- Regulation number
- 888.3060
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Memphis, TN, 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 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: recall (Z-0036-2013) | Medtronic Sofamor Danek USA Inc | 2012-10-10 |
| ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 E recall (Z-0037-2013) | Medtronic Sofamor Danek USA Inc | 2012-10-10 |
| PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Me recall (Z-0038-2013) | Medtronic Sofamor Danek USA Inc | 2012-10-10 |