FDA.reportPublic FDA data

BIOPLATE, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20294471000518793BIOPLATE, INC.1N2026-01-01570 S. Melrose St. Placentia CA US 92870

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
M3848120220Bioplate® - Plate Bender888-246-7528INFO@bioplate.com
M3848135680Bioplate® - BioMesh® Bender888-246-7528INFO@bioplate.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
505641802501744K992330THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERYJEY1999-11-23
505641278627032K980983THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERYJEY1998-06-09
505641153072430K972463THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERYJEY1997-09-25
505641814520596K961976THE BIOPLATE FIXATION SYSTEMJEY1996-08-16
505641700242980K953273BIOPLATE RIGID FIXATION BONE PLATING SYSTEMJEY1995-09-29
505641735088036K943071THE TITANIUM FIXATION SYSTEMJEY1995-01-06
505642022197815K214109PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)GXN2022-10-28
505641130049114K141880BIOPOR AOC POROUS POLYETHYLENE, CEREPORKKY2015-04-16
505641742860823K082757MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEMJEY2008-10-01
505641840027456K080507AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANTKKY2008-04-21
505641380191072K070901MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEMGXN2007-06-15
505641393868511K070901MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEMGXN2007-06-15
505641225041887K062819BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERYGXN2006-12-04
505642027928463K030806BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERYJEY2003-04-08
505641513760898K023810MODIFICATION TO BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERYJEY2002-12-04
505641563007935K023665MODIFICATION TO BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERYJEY2002-11-22
505641878109059K022890MODIFIED SCREW DESIGNS FOR USE WITH THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERYJEY2002-09-06
505641204929266K021684THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERYJEY2002-06-26
505641715155841K020088MODIFICATION OF THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEMGXN2002-02-08
505641322509727K013050THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEMGXN2001-12-10
505642066834130K002426THE BIOPLATE REGID FIXATION BONE PLATING SYSTEM FOR CRANOMAXILLOFACIAL SURGERYJEY2001-01-26
505641465929733
505641555984687
505641006086182
505641098740246
505641677287933
505641939610184
505641986620710
505641994495107
505641998090129

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JEY132008-10-01
GXN62022-10-28
KKY22015-04-16

PMN#

GUDID#

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