OWW

Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon

Product code
OWW
Device name
Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
Device class
Class 2
21 CFR
21 CFR 878.3300
Medical specialty
General, Plastic Surgery
Marketing pathway
510(K)
Flag
Implant
510(k) clearances (last 3 years)
10

FDA classification definition

For reinforcement of soft tissue where weakness exists during tendon repair procedures.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (5)

Last three years. Most recent: 2025-07-18.

NumberDecision dateApplicantDevice nameSummary
K2516552025-07-18Alafair BiosciencesVersaCoat Tendon Protector (VTP-44G2); VersaCoat TenPDF
K2500212025-02-27Nanofiber Solutions, LLCRotiumPDF
K2421872024-11-27Conmed CorporationBioBrace®PDF
K2419062024-07-29Conmed CorporationBioBrace® Reinforced ImplantPDF
K2408172024-06-14Alafair Biosciences, Inc.VersaWrapPDF

5 summaries are archived here for direct download.

Official FDA classification page: OWW
Classification and pathway per current FDA publications. Data from openFDA (CC0).