DeviceClearance

Product code OWX— General, Plastic Surgery

FiberLocker Implant; FiberLocker Instrument; FiberLocker PowerUnit

Classification name
Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
Device class
Class 2
Regulation
21 CFR 878.3300
Advisory panel
General, Plastic Surgery
Total cleared
5
First cleared
Most recent

FDA classification definition

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

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

Market context for product code OWX

FDA has cleared 5 devices under product code OWX between 2023 and 2026, filed by 3 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 OWX

Recent clearances under product code OWX

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