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PIJ — Collagen Surgical Mesh Containing Drugs Class II

FDA Device Classification

Classification Details

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

Definition

Reinforcement of soft tissue where weakness exists.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K162193c. r. bardXenMatrix AB Surgical GraftDecember 23, 2016
K151177c. r. bardXenMatrix AB Surgical GraftJuly 30, 2015
K133223c.r. bardXENMATRIX AB SURGICAL GRAFTSeptember 19, 2014