Chrysalis Intelligence · Product Codes · OXF

OXF · Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery

General, Plastic Surgery · 4 clearances · 3 unique sponsors

Device class
Class II
Regulation 878.3300
Total clearances
4
2022-12-19 → 2025-06-20
Last 12 months
0
Unique sponsors
3
Definition

What is Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery

For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery.
Medical specialty
General, Plastic Surgery
Review panel
SU
Regulation number
878.3300
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
Printbio, Inc. 2 0 2025-05-21
W. L. Gore and Associates, Inc. 1 0 2022-12-19
Acera Surgical, Inc. 1 0 2025-06-20
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
13100 CPT Medium Tissue expander(s) for other than breast; initial placement
15002 CPT Medium Surgical preparation or creation of recipient site by excision of open wounds and scar; first 100 sq cm or less
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-06-20 K251224 Acera Surgical, Inc. Restrata Soft Tissue Reinforcement (STR)
2025-05-21 K243302 Printbio, Inc. 3DMatrix DynaFlex (DynaFlex)
2024-05-23 K232602 Printbio, Inc. 3DMatrix Surgical Mesh
2022-12-19 K222919 W. L. Gore and Associates, Inc. GORE® ENFORM Biomaterial