FDA.reportPublic FDA data

Bioplate®

Primary DI
M3848135960
Brand
Bioplate®
Company
Bioplate, Inc.
Model
81-3596
Catalog number
81-3596
Device description
5-Tab Zip Implant - 20 mm
Published
2015-12-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
GXNPlate, Cranioplasty, Preformed, Non-Alterable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXNPlate, Cranioplasty, Preformed, Non-AlterableNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070901000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070901000MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEMBioplate, Inc.2007-06-15GXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M3848135960PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cranioplasty plate, non-alterableAn implantable shield designed to repair larger skull defects that is preformed before surgery and typically made of sheets of material [e.g., stainless steel, vitallium, titanium (Ti), plastic resins] that cannot be reshaped at the time of surgery without changing the physical or chemical properties of the material. The device is generally preformed with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult skull; it is usually fixed to the intact cranial bones using screws and/or other fasteners. The device is used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length20Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
00810188325044HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-08-03
00810188325181HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-08-03
00810188325204HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-08-03
00810188325174HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-31
00810188325129HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-28
00810188325105HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-27
00810188325099HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-23
00810188325112HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-23
00810188325068HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-20
00810188325075HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-20
00810188325082HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-20
00810188325051HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-17
00810188324955HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-14
00810188325013HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-14
00810188324795HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-13
00810188324948HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-13
00810188324986HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-13
00810188324931HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-10
00810188324979HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-10
00810188324924HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-09
00810188324702HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-07
00810188324917HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-06
00810188324818HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-26
00810188324849HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-26
00810188324856HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-26
00810188324672HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-22
00810188324757HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-22
00810188324788HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-22
00810188324177HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-09
00810188324719HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-09