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OWW — Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon Class II

FDA Device Classification

Classification Details

Product Code
OWW
Device Class
Class II
Regulation Number
878.3300
Submission Type
Review Panel
OR
Medical Specialty
General, Plastic Surgery
Implant
Yes

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251655alafair biosciencesVersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)July 18, 2025
K250021nanofiber solutionsRotiumFebruary 27, 2025
K242187conmed corporationBioBrace®November 27, 2024
K241906conmed corporationBioBrace® Reinforced ImplantJuly 29, 2024
K240817alafair biosciencesVersaWrapJune 14, 2024
K222220celestray biotech company, llcSpinMedix Absorbable Fibrous MembraneJuly 6, 2023
K230316international life sciencesFlexBand; FlexPatch; FlexBand PlusMay 26, 2023
K203267biorezThe BioBrace ImplantApril 30, 2021
K160364alafair biosciencesVersaWrap Tendon ProtectorJune 10, 2016
K121216soft tissue regenerationSTR GRAFTNovember 21, 2012