ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM, TRANSLATIONAL PLATE
FDA 510(k) clearance K063100 · decided 2007-02-23
Clearance details
- K-number
- K063100
- Device name
- ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM, TRANSLATIONAL PLATE
- Applicant
- Medtronic Sofamor Danek, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-10-10
- Decision date
- 2007-02-23
- Days to decision
- 136 days
- Clearance type
- Traditional
- 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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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 |
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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 |
|---|---|---|
| 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 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| PRESTIGE CERVICAL DISC SYSTEM (P060018/S005) | Medtronic Sofamor Danek, Inc. | 2016-08-11 |
| PRESTIGE® Cervical Disc (P060018/S004) | Medtronic Sofamor Danek, Inc. | 2016-07-20 |
| X-STOP LTOS (P040001/S021) | Medtronic Sofamor Danek, Inc. | 2014-12-12 |
| X-STOP PEEK INTERSPINOUS PROCESS DECOMPRESSION SYSTEM/ INTERSPINOUS SPACER SYSTEM (P040001/S022) | Medtronic Sofamor Danek, Inc. | 2014-10-24 |
| PRESTIGE CERVICAL DISC (P060018/S003) | Medtronic Sofamor Danek, Inc. | 2013-07-12 |
| X-STOP INTERSPINOUS SPACER SYSTEM (P040001/S020) | Medtronic Sofamor Danek, Inc. | 2012-07-25 |
| X-STOP INTERSPINOUS SPACER SYSTEM (P040001/S019) | Medtronic Sofamor Danek, Inc. | 2011-05-04 |
| PRESTIGE CERVICAL DISC (P060018/S002) | Medtronic Sofamor Danek, Inc. | 2011-03-24 |