Chrysalis Intelligence · Product Codes · JXI

JXI · Cuff, Nerve

Neurology · 15 clearances · 10 unique sponsors

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals
Device class
Class II
Regulation 882.5275
Total clearances
15
2020-09-14 → 2026-04-09
Last 12 months
2
Unique sponsors
10
Classification details
Medical specialty
Neurology
Review panel
NE
Regulation number
882.5275
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
Alafair Biosciences, Inc. 4 0 2025-07-22
Axogen Corporation 2 0 2023-10-12
Biocircuit Technologies, Inc. 2 0 2025-04-02
Auxilium Biotechnologies, Inc. 1 1 2026-01-17
Mochida Pharmaceutical Co., Ltd. 1 0 2024-06-21
Biocircuit Technologies, Incorporated 1 0 2022-07-15
KLISBio S.r.l. 1 1 2026-04-09
Celestray Biotech Company, LLC., 1 0 2024-01-29
Orthocell, Ltd. 1 0 2025-04-02
Renerve, Ltd. 1 0 2022-02-10
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
64610 CPT — Medium CPT code for nerve block procedures that may use nerve cuff devices
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-04-09 K260245 KLISBio S.r.l. SILKBridge
2026-01-17 K253363 Auxilium Biotechnologies, Inc. NeuroSpan Bridge
2025-07-22 K251505 Alafair Biosciences VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)
2025-07-17 K251175 Alafair Biosciences VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)
2025-04-02 K243889 Orthocell, Ltd. Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)
2025-04-02 K242113 Biocircuit Technologies, Inc. Nerve Wrap (07-DW-001-TAB)
2024-06-21 K233322 Mochida Pharmaceutical Co., Ltd. Mochida Nerve Cuff
2024-02-12 K233533 Biocircuit Technologies, Inc. NerveTape
2024-01-29 K230794 Celestray Biotech Company, LLC., Rebuilder Nerve Guidance Conduit
2023-11-02 K232029 Alafair Biosciences, Inc. VersaWrap Nerve Protector
2023-10-12 K231708 Axogen Corporation Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48)
2023-04-07 K223640 Axogen Corporation Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48)
2022-07-15 K210665 Biocircuit Technologies, Incorporated Nerve Tape
2022-02-10 K202234 Renerve, Ltd. NervAlign Nerve Cuff
2020-09-14 K201631 Alafair Biosciences, Inc. VersaWrap Nerve Protector
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence