BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY

Plate, Cranioplasty, Preformed, Non-alterable

BIOPLATE, INC.

The following data is part of a premarket notification filed by Bioplate, Inc. with the FDA for Bioplate Rigid Bone Plating System For Craniomaxillofacial Surgery.

Pre-market Notification Details

• Device ID: K062819
• 510k Number: K062819
• Device Name: BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
• Classification: Plate, Cranioplasty, Preformed, Non-alterable
• Applicant: BIOPLATE, INC. 3643 LENAWEE AVE. Los Angeles, CA 90016 -4310
• Contact: Jesus T Farinas
• Correspondent: Jesus T Farinas; BIOPLATE, INC. 3643 LENAWEE AVE. Los Angeles, CA 90016 -4310
• Product Code: GXN
• CFR Regulation Number: 882.5330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-09-20
• Decision Date: 2006-12-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M384815791US0	K062819	000
M384815791CP0	K062819	000
M3848157910	K062819	000