Chrysalis Intelligence · Product Codes · OWY

OWY · Unclassified

9 clearances · 6 unique sponsors

Device class
Regulation —
Total clearances
9
2020-10-19 → 2025-09-30
Last 12 months
2
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
Embody, Inc. 4 1 2025-09-19
Smith & Nephew Inc., Endoscopy Div. 1 0 2024-11-26
Tybr Health 1 0 2025-06-06
Arthrex, Inc. 1 1 2025-09-30
Smith and Nephew, Inc. 1 0 2023-05-11
Kerecis Limited 1 0 2025-06-04
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
2025-09-30 K251690 Arthrex, Inc. Arthrex SpeedFLEX™ Implant
2025-09-19 K252647 Embody, Inc. Tapestry Biointegrative Implant
2025-06-06 K250109 Tybr Health TYBR Collagen Gel
2025-06-04 K243843 Kerecis Limited Tendon Protect (50242)
2024-11-26 K242631 Smith & Nephew Inc., Endoscopy Div. REGENETEN™ Bioinductive Implant
2023-05-11 K222501 Smith and Nephew, Inc. Regeneten Bioinductive Implant
2022-05-23 K220867 Embody, Inc. Tapestry Biointegrative Implant
2021-11-02 K212306 Embody, Inc. Tapestry Biointegrative Implant
2020-10-19 K201572 Embody, Inc. TAPESTRY Biointegrative Implant