FDA.reportPublic FDA data

NA

Primary DI
07613327129243
Brand
NA
Company
Stryker Leibinger GmbH & Co. KG
Model
78-40100
Catalog number
78-40100
Device description
PEEK CUSTOMIZED-CRANIOFACIAL
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
GWOPlate, cranioplasty, preformed, alterable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWOPlate, Cranioplasty, Preformed, AlterableNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152076000
K190229000
K203055000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152076000PEEK Customized Cranial Implant, PEEK Customized Cranial Implant PriorityStryker2015-08-26GWO
K190229000Stryker PEEK Customized Cranial Implant KitStryker2019-07-11GWO
K203055000Stryker PEEK Customized Cranial Implant KitStryker2021-02-09GWO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327129243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327129243076133271292437613327129243

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
316153956
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327300086NA78-8002078-800202021-01-27
07613327300109NA78-8004078-800402021-01-27
07613327300123NA78-8003078-800302021-01-27
04546540730763NA78-1001078-100102015-07-03
04546540730787NA78-1003078-100302015-07-03
04546540730794NA78-1004078-100402015-07-03
04546540730800NA78-1010078-101002015-07-03
07613327004021NA78-1002078-100202015-07-03
07613327129236NA78-4001078-400102015-09-24
07613327129250NA78-4004078-400402015-09-24
07613327129267NA78-5003078-500302015-09-24
07613327129274NA78-5004078-500402015-09-24
07613327129281NA78-5002078-500202015-09-24
07613327129298NA78-4003078-400302015-09-24
07613327129328NA78-5001078-500102015-09-24
07613327129335NA78-4002078-400202015-09-24
07613327300017NA78-7002078-700202017-02-21
07613327300031NA78-7004078-700402017-02-21
07613327300055NA78-7003078-700302017-02-21
07613327300062NA78-6003078-600302017-02-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810125929878CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-06
00810125929885CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-06
00810125929663CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-02
00810125929670FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-06-02
00810125929625CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-01
00810125929632CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-01
00810125929649CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-01
00810125929656CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-01
08806390889049Leforte Neuro System Bone PlateJeil Medical CorporationGWO2023-11-30
G28440901KTC Burr Hole CoverNeurovention LLCGWO2022-06-21
G28441001KTC Burr Hole CoverNeurovention LLCGWO2022-06-21
08806390888851Leforte Neuro System Bone PlateJeil Medical CorporationGWO2022-05-03
07613327300086NAStryker Leibinger GmbH & Co. KGGWO2021-01-27
07613327300109NAStryker Leibinger GmbH & Co. KGGWO2021-01-27
07613327300123NAStryker Leibinger GmbH & Co. KGGWO2021-01-27
08809595972844Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-12-30
08809595972851Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-12-30
08809595972875Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-12-30
08809595972899Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-12-30
08809416061542Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14
08809416061559Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14
08809416061566Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14
08809416061573Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14
08809416061580Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14
08809416061603Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14
08809416061627Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14
08809416061634Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14
08809416061641Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14
08809416061658Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14