FDA.reportPublic FDA data

NA

Primary DI
07613327300079
Brand
NA
Company
Stryker Leibinger GmbH & Co. KG
Model
78-70010
Catalog number
78-70010
Device description
PEEK CUSTOMIZED-PLUS-S
Published
2017-02-21
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
K153248000
K190229000
K203055000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152076000PEEK Customized Cranial Implant, PEEK Customized Cranial Implant PriorityStryker2015-08-26GWO
K153248000PEEK Customized Cranial ImplantStryker2016-03-10GWO
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
07613327300079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327300079076133273000797613327300079

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.

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
07613327129243NA78-4010078-401002015-09-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810125929861CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-06
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