Chrysalis Intelligence · Product Codes · GXR

GXR · Cover, Burr Hole

Neurology · 5 clearances · 5 unique sponsors

Device class
Class II
Regulation 882.5250
Total clearances
5
2020-03-13 → 2026-03-16
Last 12 months
1
Unique sponsors
5
Medical specialty
Neurology
Review panel
NE
Regulation number
882.5250
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
Neurovention, LLC 1 0 2020-03-13
Chendu Medart Medical Scientific Co., Ltd. 1 0 2023-11-21
Ossaware Biotech Co., Ltd. 1 0 2020-06-03
Neos Surgery S.L 1 0 2024-02-16
Orthocon, Inc. 1 1 2026-03-16
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
62000 CPT Medium Elevation of depressed skull fracture; burr hole cover used during cranial access procedures
20999 CPT Low Unlisted procedure, musculoskeletal system; when specific burr hole coverage not otherwise classified
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-03-16 K253447 Orthocon, Inc. Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)
2024-02-16 K240137 Neos Surgery S.L Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System
2023-11-21 K221606 Chendu Medart Medical Scientific Co., Ltd. Absorbable Cranial Flap Fixation System
2020-06-03 K192310 Ossaware Biotech Co., Ltd. Flap Fixator, Burr Hole Cover
2020-03-13 K192162 Neurovention, LLC NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate