THE BIOPLATE REGID FIXATION BONE PLATING SYSTEM FOR CRANOMAXILLOFACIAL SURGERY

Plate, Bone

BIOPLATE, INC.

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

Pre-market Notification Details

• Device ID: K002426
• 510k Number: K002426
• Device Name: THE BIOPLATE REGID FIXATION BONE PLATING SYSTEM FOR CRANOMAXILLOFACIAL SURGERY
• Classification: Plate, Bone
• Applicant: BIOPLATE, INC. 6911 MELROSE AVE. Los Angeles, CA 90038
• Contact: Carol E Jones
• Correspondent: Carol E Jones; BIOPLATE, INC. 6911 MELROSE AVE. Los Angeles, CA 90038
• Product Code: JEY
• CFR Regulation Number: 872.4760 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-08-08
• Decision Date: 2001-01-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M384P2BX04100	K002426	000
M384P2CW0830US0	K002426	000
M384P2CW10370	K002426	000
M384P2HP07170	K002426	000
M384P2LL07230	K002426	000
M384P2LR07230	K002426	000
M384P2LW04130	K002426	000
M384P2LW04150	K002426	000
M384P2LW04170	K002426	000
M384P2LW05210	K002426	000
M384P2CW08300	K002426	000
M384P2CW06270	K002426	000
M384P2BX04140	K002426	000
M384P2BX08240	K002426	000
M384P2CB04190	K002426	000
M384P2CB06270	K002426	000
M384P2CP04150	K002426	000
M384P2CP06230	K002426	000
M384P2CP08450	K002426	000
M384P2CW04190	K002426	000
M384P2CW06230	K002426	000
M384P2LW0521US0	K002426	000
M384P2LW07230	K002426	000
M384P2LW0723US0	K002426	000
M384P2RW0723US0	K002426	000
M384P2SB02110	K002426	000
M384P2SB02140	K002426	000
M384P2SB0214051	K002426	000
M384P2SB0214501	K002426	000
M384P2SB0214US0	K002426	000
M384P2SB04170	K002426	000
M384P2SB04190	K002426	000
M384P2SB04210	K002426	000
M384P2RW07230	K002426	000
M384P2RW0521US0	K002426	000
M384P2NW06170	K002426	000
M384P2NW0617US0	K002426	000
M384P2RP05330	K002426	000
M384P2RP17340	K002426	000
M384P2RP1734US0	K002426	000
M384P2RW04130	K002426	000
M384P2RW04150	K002426	000
M384P2RW04170	K002426	000
M384P2RW05210	K002426	000
M384P2ST04150	K002426	000
M384P2BN08240	K002426	000
M3848120001	K002426	000
M384813018US0	K002426	000
M3848130271	K002426	000
M384813027US1	K002426	000
M3848130280	K002426	000
M384813028CP1	K002426	000
M384813028US0	K002426	000
M3848130340	K002426	000
M384813034CP1	K002426	000
M384813034US0	K002426	000
M384813018CP1	K002426	000
M3848130180	K002426	000
M384812000US1	K002426	000
M3848120010	K002426	000
M384812001CP1	K002426	000
M384812001US0	K002426	000
M3848120030	K002426	000
M384812003CP1	K002426	000
M384812003US0	K002426	000
M3848120040	K002426	000
M384812004US0	K002426	000
M3848130350	K002426	000
M384813035CP1	K002426	000
M384813035US0	K002426	000
M384813136US0	K002426	000
M3848131380	K002426	000
M384813138CP1	K002426	000
M384813138US0	K002426	000
M3848131610	K002426	000
M384813161CP1	K002426	000
M384813161US0	K002426	000
M3848133021	K002426	000
M3848135191	K002426	000
M384813136CP1	K002426	000
M3848131360	K002426	000
M3848130480	K002426	000
M384813048CP1	K002426	000
M384813048US0	K002426	000
M3848131310	K002426	000
M384813131CP1	K002426	000
M384813131US0	K002426	000
M3848131321	K002426	000
M3848131351	K002426	000
M384813135US1	K002426	000
M384P1MC80990	K002426	000
M384P2ST08310	K002426	000
M384P4LL04170	K002426	000
M384P4ST04240	K002426	000
M384P4ST0424US0	K002426	000
M384P4ST08480	K002426	000
M384P4TP06240	K002426	000
M384P4TP0624US0	K002426	000
M384P4XB08390	K002426	000
M384P4XP06200	K002426	000
M384P4XP06260	K002426	000
M384P4YP05220	K002426	000
M384P4SB06430	K002426	000
M384P4SB04300	K002426	000
M384P4LL04200	K002426	000
M384P4LL05280	K002426	000
M384P4LL07400	K002426	000
M384P4LR04170	K002426	000
M384P4LR04200	K002426	000
M384P4LR05280	K002426	000
M384P4LR07400	K002426	000
M384P4MC2000	K002426	000
M384P4SB04270	K002426	000
M384P4YP0522US0	K002426	000
M384P4YP09450	K002426	000
M384P4ZL04210	K002426	000
M384P8ST16620	K002426	000
M384P8ST1662US0	K002426	000
M384P8TP05140	K002426	000
M384P8TP0514US0	K002426	000
M384P8XP07160	K002426	000
M384P8XP0716US0	K002426	000
M384P8YP06170	K002426	000
M384P8YP0617US0	K002426	000
M384P2MC1200	K002426	000
M384P8ST0622US0	K002426	000
M384P8ST06220	K002426	000
M384P4ZR04210	K002426	000
M384P8BN06160	K002426	000
M384P8BN0616US0	K002426	000
M384P8BX04090	K002426	000
M384P8BX0409US0	K002426	000
M384P8CP08290	K002426	000
M384P8CP0829US0	K002426	000
M384P8HP07160	K002426	000
M384P8HP11180	K002426	000
M384P2ST16630	K002426	000
M384P4IP06240	K002426	000
M384P2ST32990	K002426	000
M384P2TB05150	K002426	000
M384P2TB05190	K002426	000
M384P2TB05240	K002426	000
M384P2TW04170	K002426	000
M384P2TW05190	K002426	000
M384P2XB06170	K002426	000
M384P2XP04140	K002426	000
M384P2XP06130	K002426	000
M384P2XP07170	K002426	000
M384P2TB04200	K002426	000
M384P2TB04170	K002426	000
M384P2SW04150	K002426	000
M384P2SW04170	K002426	000
M384P2SW06230	K002426	000
M384P2SW0623US0	K002426	000
M384P2SW08310	K002426	000
M384P2SW16630	K002426	000
M384P2SW1663US0	K002426	000
M384P2SW24950	K002426	000
M384P2TB04160	K002426	000
M384P2XW06130	K002426	000
M384P2XW07170	K002426	000
M384P2XW0717US0	K002426	000
M384P3SB0212051	K002426	000
M384P3SB02121	K002426	000
M384P3SB04200	K002426	000
M384P3ST16860	K002426	000
M384P3XB06180	K002426	000
M384P4CP08450	K002426	000
M384P4CP0845US0	K002426	000
M384P4HP08260	K002426	000
M384P4IP04170	K002426	000
M384P3MC80990	K002426	000
M384P3MC1200	K002426	000
M384P2YB05180	K002426	000
M384P2YP06180	K002426	000
M384P2YW06180	K002426	000
M384P2YW0618US0	K002426	000
M384P2ZL04160	K002426	000
M384P2ZR04160	K002426	000
M384P3BX04110	K002426	000
M384P3BX04150	K002426	000
M384P3CP08450	K002426	000
M384P4IP0417US0	K002426	000