FDA Product Code OWW: Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
For Reinforcement Of Soft Tissue Where Weakness Exists During Tendon Repair Procedures.
Leading manufacturers include Conmed Corporation, Celestray Biotech Company, LLC., and International Life Sciences.
FDA 510(k) Cleared Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon Devices (Product Code OWW)
About Product Code OWW - Regulatory Context
510(k) Submission Activity
10 total 510(k) submissions under product code OWW since 2012, with 10 receiving FDA clearance (average review time: 130 days).
Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under OWW have taken an average of 68 days to reach a decision - down from 193 days historically, suggesting improved FDA processing for this classification.
OWW devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →