FDA.reportPublic FDA data

Bioplate®

Primary DI
M3848158850
Brand
Bioplate®
Company
Bioplate, Inc.
Model
81-5885
Catalog number
81-5885
Device description
X Plate - Low-Profile - 6 hole - 17 mm (1), Self-Drilling Screw - 4 mm (6) [5 PK]
Published
2015-12-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone
JEYPlate, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
JEYPlate, BoneDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082757000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082757000MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEMBioplate, Inc.2008-10-01JEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M3848158851PackageHIBCC5In Commercial Distribution
M3848158850PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial fixation plate, non-bioabsorbable, non-customizedA small, implantable, non-customized sheet of firm material designed to be attached with screws to craniofacial bone (including the maxilla and/or mandible) to bridge and stabilize a fracture gap or craniotomy flap, cover a burr hole and/or position/stabilize a prosthesis. It is made of non-bioabsorbable materials (e.g., surgical steel, titanium alloy) and is available in a variety of designs (e.g., Y-plate, curved plate, mesh-panel, burr hole cover). Instruments intended to facilitate implantation (e.g., driver), or plate fixation implants (i.e., bone screws), may be packaged with the plate.

Contacts#

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

Regulatory Flags#

DUNS number
838734093
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
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

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Primary DI, Brand, Company table
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