FDA.reportPublic FDA data

Bioplate®

Primary DI
M3848133640
Brand
Bioplate®
Company
Bioplate, Inc.
Model
81-3364
Catalog number
81-3364
Device description
Xpress® Compact Kit
Published
2018-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument
HTDForceps
JEYPlate, Bone
LRZScrewdriver, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1
HTDForcepsGeneral, Plastic Surgery1
JEYPlate, BoneDental2
LRZScrewdriver, SurgicalGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K943071000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K943071000THE TITANIUM FIXATION SYSTEMBiomedics1995-01-06JEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M3848133640PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterileA non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
888-246-7528INFO@bioplate.com

Regulatory Flags#

DUNS number
838734093
Device count
1
Kit
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M3848157370Bioplate®81-573781-57372026-02-09
M3848157380Bioplate®81-573881-57382026-02-09
M3848157390Bioplate®81-573981-57392026-02-09
M3848120220Bioplate®81-202281-20222018-10-22
M3848135680Bioplate®81-356881-35682018-10-23
M384813568CP0Bioplate®81-3568-CP81-3568-CP2019-02-25
M384ABP2100Bioplate®ABP2-10ABP2-102018-10-23
M384ABP2300Bioplate®ABP2-30ABP2-302018-10-23
M384ABP4300Bioplate®ABP4-30ABP4-302018-10-23
M384AMB3300Bioplate®AMB3-30AMB3-302018-10-29
M384ABP230SALE0Bioplate®ABP2-30-SALEABP2-30-SALE2019-10-15
M384ABP430SALE0Bioplate®ABP4-30-SALEABP4-30-SALE2019-10-15
M3848120930Bioplate®81-209381-20932015-12-03
M3848135730Bioplate®81-357381-35732015-12-03
M384813573US0Bioplate®81-3573[US]81-3573[US]2016-05-27
M3848135740Bioplate®81-357481-35742015-12-03
M3848135750Bioplate®81-357581-35752015-12-03
M3848135780Bioplate®81-357881-35782015-12-03
M3848135790Bioplate®81-357981-35792015-12-03
M3848135800Bioplate®81-358081-35802015-12-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840286860086Consensus Knee SystemShalby Advanced Technologies, Inc.FSM2026-07-09
M697X07900081Silex Sacroiliac Joint Fusion SystemXtant Medical Holdings, Inc.FSM2026-07-08
00840456220283JMUJMU DENTAL, INCFSM2026-07-07
00190446907466EF1Medshape, Inc.FSM2026-06-25
00190446907473EF1Medshape, Inc.FSM2026-06-25
04046826346812MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826416676MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826542337MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826543655MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826552473MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
00190776421724MillenniumAvalign Technologies, Inc.FSM2026-06-24
00190776421786MillenniumAvalign Technologies, Inc.HTD2026-06-24
00192896123502Stefan Bone Holding ForcepsSONTEC INSTRUMENTS, INC.HTD2026-06-24
00192896123519Rochester Carmalt ForcepsSONTEC INSTRUMENTS, INC.HTD2026-06-24
00192896123526Rochester Carmalt ForcepsSONTEC INSTRUMENTS, INC.HTD2026-06-24
00192896123533Rochester Carmalt ForcepsSONTEC INSTRUMENTS, INC.HTD2026-06-24
00885556924730EVOSSmith & Nephew, Inc.FSM2026-06-24
00810158210837PRINCETONPrinceton Medical Group, Inc.HTD2026-06-23
00810158211100PRINCETONPrinceton Medical Group, Inc.HTD2026-06-23
00810158211117PRINCETONPrinceton Medical Group, Inc.HTD2026-06-23
00810158211148PRINCETONPrinceton Medical Group, Inc.HTD2026-06-23
00810158211186PRINCETONPrinceton Medical Group, Inc.HTD2026-06-23
00810158211216PRINCETONPrinceton Medical Group, Inc.HTD2026-06-23
00810158211223PRINCETONPrinceton Medical Group, Inc.HTD2026-06-23
00840456200308JMUJMU DENTAL, INCFSM2026-06-23
00840456200315JMUJMU DENTAL, INCFSM2026-06-23
00840456201176JMUJMU DENTAL, INCFSM2026-06-23
00840456201206JMUJMU DENTAL, INCFSM2026-06-23
00840456201213JMUJMU DENTAL, INCFSM2026-06-23
00840456201220JMUJMU DENTAL, INCFSM2026-06-23