Chrysalis Intelligence · Product Codes · PLR

PLR · Unclassified

8 clearances · 6 unique sponsors

Device class
Regulation —
Total clearances
8
2020-02-24 → 2026-07-15
Last 12 months
2
Unique sponsors
6
Medical specialty
Review panel
Regulation number
Implant
Life-sustain / support
GMP exempt
Third-party review
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Bright Spine 2 0 2023-01-13
Atlas Spine, Inc. 2 2 2026-07-15
K2m, Inc. 1 0 2022-02-24
Nexxt Spine, LLC 1 0 2020-02-24
Cmf Medicon Surgical, Inc. 1 0 2022-04-04
MiRus, LLC 1 0 2023-10-13
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
22548 CPT High Arthrodesis, anterior transoral approach; cervical spine fusion with body replacement device
63081 CPT High Vertebral body replacement procedures; anterior cervical approach codes
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-07-15 K252822 Atlas Spine, Inc. Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy Implant
2025-11-10 K252560 Atlas Spine, Inc. Atlas Spine HiRISE™ Expandable Cervical Corpectomy System
2023-10-13 K232481 MiRus, LLC RIGEL™ 3DR Anterior Cervical Corpectomy System
2023-01-13 K221542 Bright Spine Galileo Vertebral Body Replacement Device
2022-04-04 K212126 Cmf Medicon Surgical, Inc. MediExpand Cervical Expandable VBR System
2022-02-24 K211320 K2m, Inc. CAPRI Corpectomy Cage System
2020-04-21 K192145 Bright Spine Galileo Vertebral Body Replacement Device
2020-02-24 K193412 Nexxt Spine, LLC NEXXT MATRIXX System