Chrysalis Intelligence · Product Codes · GXQ

GXQ · Dura Substitute

Neurology · 4 clearances · 4 unique sponsors

Device class
Class II
Regulation 882.5910
Total clearances
4
2022-01-28 → 2025-11-18
Last 12 months
1
Unique sponsors
4
Medical specialty
Neurology
Review panel
NE
Regulation number
882.5910
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
Collagen Matrix, Inc. 1 1 2025-11-18
Synthes (USA) Products, LLC 1 0 2022-01-28
Helios Biomedical, Inc. 1 0 2025-05-14
Nurami Medical , Ltd. 1 0 2023-08-10
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
62010 CPT Medium Repair of dura mater and/or meninges; dura substitutes used in repair/reconstruction procedures
64999 CPT Low Unlisted procedure, nervous system; if substitute used in non-standard reconstruction
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-11-18 K251191 Collagen Matrix, Inc. Collagen Dura Regeneration Membrane - Repair
2025-05-14 K250420 Helios Biomedical, Inc. Helios Dura Regeneration Matrix
2023-08-10 K223445 Nurami Medical , Ltd. ArtiFascia
2022-01-28 K212943 Synthes (USA) Products, LLC SyntheCel Dura Repair