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.
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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
M384815791US0 | K062819 | 000 |
M384815791CP0 | K062819 | 000 |
M3848157910 | K062819 | 000 |