Chrysalis Intelligence · Product Codes · OWW

OWW · Unclassified

8 clearances · 6 unique sponsors

Device class
Regulation —
Total clearances
8
2021-04-30 → 2025-07-18
Last 12 months
0
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
Conmed Corporation 2 0 2024-11-27
Alafair Biosciences, Inc. 2 0 2025-07-18
Celestray Biotech Company, LLC., 1 0 2023-07-06
Nanofiber Solutions, LLC 1 0 2025-02-27
Biorez, Inc. 1 0 2021-04-30
International Life Sciences 1 0 2023-05-26
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
24341 CPT Medium Repair, tendon or muscle, upper arm or elbow area; primary, single, each tendon or muscle
28200 CPT Medium Repair, tendon, flexor, foot; primary or secondary, without free graft, each tendon
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-07-18 K251655 Alafair Biosciences VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)
2025-02-27 K250021 Nanofiber Solutions, LLC Rotium
2024-11-27 K242187 Conmed Corporation BioBrace®
2024-07-29 K241906 Conmed Corporation BioBrace® Reinforced Implant
2024-06-14 K240817 Alafair Biosciences, Inc. VersaWrap
2023-07-06 K222220 Celestray Biotech Company, LLC., SpinMedix Absorbable Fibrous Membrane
2023-05-26 K230316 International Life Sciences FlexBand; FlexPatch; FlexBand Plus
2021-04-30 K203267 Biorez, Inc. The BioBrace Implant