ATLANTIS Anterior Cervical Plate System
FDA 510(k) clearance K152623 · decided 2015-11-12
Clearance details
- K-number
- K152623
- Device name
- ATLANTIS Anterior Cervical Plate System
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-09-14
- Decision date
- 2015-11-12
- Days to decision
- 59 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
+ Add to Predicate Builder ◉ Watch Medtronic Sofamor Danek USA
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
|---|---|---|
| INFUSE® Bone Graft/LT-Cage Lumbar Tapered Fusion Device (P000058/S094) | Medtronic Sofamor Danek USA, Inc. | 2025-03-19 |
| INFUSE® Bone Graft (P000054/S074) | Medtronic Sofamor Danek USA, Inc. | 2025-03-19 |
| INFUSE Bone Graft/Medtronic Interbody Fusion Device (P000058/S093) | Medtronic Sofamor Danek USA, Inc. | 2024-11-06 |
| INFUSE Bone Graft (P000054/S073) | Medtronic Sofamor Danek USA, Inc. | 2024-11-06 |
| Prestige LP (R) Cervical Disc (P090029/S021) | Medtronic Sofamor Danek USA, Inc. | 2024-08-09 |
| Prestige LP (R) Cervical Disc (P090029/S020) | Medtronic Sofamor Danek USA, Inc. | 2024-05-01 |
| Prestige LP Cervical Disc (P090029/S018) | Medtronic Sofamor Danek USA, Inc. | 2024-02-21 |
| Prestige LP® Cervical Disc (P090029/S019) | Medtronic Sofamor Danek USA, Inc. | 2023-10-26 |