Chrysalis Intelligence · Product Codes · MVA

MVA · Orthosis, Cranial

Neurology · 8 clearances · 5 unique sponsors

Device class
Class II
Regulation 882.5970
Total clearances
8
2021-03-26 → 2024-08-30
Last 12 months
0
Unique sponsors
5
Medical specialty
Neurology
Review panel
NE
Regulation number
882.5970
Implant
N
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
Invent Medical USA, LLC 3 0 2024-08-30
Otto Bock Healthcare LP 2 0 2022-06-09
Headstart, Ltd. 1 0 2021-06-07
Orthomerica Products, Inc. 1 0 2023-04-20
Symbion Logistics, LLC 1 0 2022-07-01
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
L3825 HCPCS — High HCPCS for cranial orthosis
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2024-08-30 K241957 Invent Medical USA, LLC Talee, Talee PostOp
2023-06-22 K230444 Invent Medical USA, LLC Talee, Talee PostOp
2023-04-20 K223238 Orthomerica Products, Inc. STARband 3D
2022-09-22 K220681 Invent Medical USA, LLC Talee, Talee PostOP
2022-07-01 K203134 Symbion Logistics, LLC Hanger Cranial Band 3D
2022-06-09 K213587 Otto Bock Healthcare LP MyCRO Band
2021-06-07 K193383 Headstart, Ltd. SnugKap
2021-03-26 K201426 Otto Bock Healthcare LP MyCRO Band