Chrysalis Intelligence · Product Codes · NQW

NQW · Orthosis, Spine, Plate, Laminoplasty, Metal

Orthopedic · 6 clearances · 4 unique sponsors

Device class
Class II
Regulation 888.3050
Total clearances
6
2021-12-13 → 2026-05-27
Last 12 months
1
Unique sponsors
4
Definition

What is Orthosis, Spine, Plate, Laminoplasty, Metal

This device is a plate that is attached to the lamina after a laminoplasty or laminectomy procedure.
Medical specialty
Orthopedic
Review panel
OR
Regulation number
888.3050
Implant
Y
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Vy Spine, LLC 2 0 2024-10-16
Curiteva, Inc. 2 0 2024-10-28
ZheJiang Decans Medical Devices Co., Ltd. 1 1 2026-05-27
Medtronic Sofamor Danek 1 0 2021-12-13
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
63050 CPT High Laminoplasty with internal fixation; metal plate placement in laminoplasty procedure
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-05-27 K252930 ZheJiang Decans Medical Devices Co., Ltd. AQUA Laminoplasty Systems
2024-10-28 K243137 Curiteva, Inc. Curiteva Porous PEEK Laminoplasty System
2024-10-16 K242784 Vy Spine, LLC Vy Spine™ VyLam™ Laminoplasty System
2023-10-10 K232471 Vy Spine, LLC Vy Spine™ VyLam™ Laminoplasty System
2023-06-28 K231232 Curiteva, Inc. Curiteva Laminoplasty System
2021-12-13 K212428 Medtronic Sofamor Danek Centerpiece Plate Fixation System