FDA.reportPublic FDA data

Bioplate®

Primary DI
M384P2MC1200
Brand
Bioplate®
Company
Bioplate, Inc.
Model
P2MC-120
Catalog number
P2MC-120
Device description
BioMesh® 2MC - 120 mm Round
Published
2019-10-15
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
JEYPlate, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEYPlate, BoneDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002426000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002426000THE BIOPLATE REGID FIXATION BONE PLATING SYSTEM FOR CRANOMAXILLOFACIAL SURGERYBioplate, Inc.2001-01-26JEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M384P2MC1200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose surgical mesh, metallicA sterile flat woven/knitted material made of a biocompatible metal (e.g., surgical stainless steel, tantalum) with appropriate mechanical characteristics for implantation. This non-dedicated device is used alone or in combination with synthetic materials (e.g., polymers) to support or protect tissues in reconstructive surgical procedures (e.g., to repair large chest wall defects or large abdominal incisional hernias) and/or orthopaedic procedures (e.g., cranioplasty, femoral reconstruction). Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length120Millimeter

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
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
08809233620106ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620113ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620120ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620137ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620144ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620151ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620168ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620182ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620199ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620205ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620298ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620304ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620311ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620335ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620342ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620366ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620380ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620397ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620403ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620410ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620427ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620489ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620502ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620526ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620533ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620540ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620557ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620625ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620632ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620649ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11