DeviceClearance

Product code OWW— General, Plastic Surgery

BioBrace®

Classification name
Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
Device class
Class 2
Regulation
21 CFR 878.3300
Advisory panel
General, Plastic Surgery
Total cleared
10
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code OWW under 21 CFR 878.3300, via openFDA

Market context for product code OWW

FDA has cleared 10 devices under product code OWW between 2012 and 2025, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OWW

Recent clearances under product code OWW

Data sourced from openFDA. This site is unofficial and independent of the FDA.