Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2029447

FEI Number

1000518793

Entity Name

BIOPLATE, INC.

City/State/Country

Placentia, CA, US

Establishment Address

570 S. Melrose St., Placentia, CA 92870, US

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Bioplate, Inc. (Owner Number: 9016123)

Owner / Operator Contact Address

570 S. Melrose St., Placentia, CA 92870, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K980983

PMA Number

N/A

All Registered Proprietary Names

Rigid Fixation Bone Plating System Bioplate Plate Cutter / Mesh Cutting Scissors The Titanium Fixation System Titanium Fixation System CranioFit Bioplate Rigid Fixation Bone Bioplate Titanium Fixation System Bioplate Plate Bender The Bioplate Rigid Bone Plating System for Craniomaxillofacial Surgery Modified Sterile Plate & Screw kit configurations for use with Bioplate Titanium Fixation System Screws for Rigid Fixation Bone Plating System Bioplate Forceps, Plate Holding The Bioplate Rigid Fixation bone plating system for Craniomaxillofacial surgery The Bioplate Rigid Fixation System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JEY	Plate, Bone	Dental	Class 2	872.4760	2008-02-28
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-04-17
JEY	Plate, Bone	Dental	Class 2	872.4760	2015-12-01
JEY	Plate, Bone	Dental	Class 2	872.4760	2015-12-01
GXN	Plate, Cranioplasty, Preformed, Non-Alterable	Neurology	Class 2	882.5330	2024-07-26
JEY	Plate, Bone	Dental	Class 2	872.4760	2008-02-28
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2015-12-02
LRZ	Screwdriver, Surgical	General, Plastic Surgery	Class 1	878.4800	2015-12-01
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	2024-04-17
JEY	Plate, Bone	Dental	Class 2	872.4760	2015-12-01
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-12-01
JEY	Plate, Bone	Dental	Class 2	872.4760	2015-12-01
JEY	Plate, Bone	Dental	Class 2	872.4760	2008-02-28
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2024-04-17
JEY	Plate, Bone	Dental	Class 2	872.4760	2015-12-01

Official Correspondent

Yoon Choi

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Bioplate, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K172572	Stryker	Stryker Upper-Face AXS screws and Mid-Face AXS screws	2017-10-31
K121589	Biomet Microfixation	BIOMET MICROFIXATION FACIAL PLATING SYSTEM	2012-09-21
K984230	Osteogenics Biomedical, Inc.	OSTEO-MESH TM-300	1999-02-04
K021618	Osteomed Corp.	OSA RIGID INTERNAL FIXATION SYSTEM	2002-08-08
K180121	Cellumed Co., Ltd.	Rafugen DBM	2018-04-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0043-2007	Bioplate Inc	2	Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45
Z-0040-2018	Genesys Orthopedics Systems, LLC 1250 S Capital of Texas Hwy Ste 600 Bldg # 3 West Lake Hills TX 78746-6446	1	Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System The Genesys Spine Binary Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis, or scoliosis),pseudoarthrosis, failed previous fusion, and/or spinal stenosis.
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201

Similar Registrations

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2029447. Last updated year: 2026. Please use registration number 2029447 when referencing this establishment in official correspondence.