FDA.reportPublic FDA data

NA

Primary DI
07613327129236
Brand
NA
Company
Stryker Leibinger GmbH & Co. KG
Model
78-40010
Catalog number
78-40010
Device description
PEEK Customized Cranial Implant, S
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
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
07613327129236PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327129236076133271292367613327129236

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
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
37613154881872PINABALL6003-003-0906003-003-0902016-09-21
57613252088436TLS, Quintube663066302016-08-24
07613327465532NA92-0023292-002322019-05-03
07613327465549NA92-0023092-002302019-05-03
04546540134790NA01-0323001-032302017-01-11
04546540134974NA01-0401001-040102016-12-08
04546540134998NA01-0407001-040702016-12-08
04546540135018NA01-0410001-041002016-12-08
04546540138477NA01-0956101-095612016-12-08
04546540141514NA01-1531501-153152017-01-11
04546540143242NA01-1971501-197152016-12-08
04546540143273NA01-1973001-197302016-12-08
04546540166623NA09-0146109-014612017-01-11
04546540166630NA09-0146209-014622017-01-11
04546540215161NA37-1027237-102722016-12-08
04546540215222NA37-1041137-104112016-12-08
04546540215291NA37-1093037-109302016-12-08
04546540215413NA37-1246137-124612016-12-08
04546540217059NA41-3679241-367922016-12-08
04546540217066NA41-3679341-367932016-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
09349797002547StarPoreANATOMICS PTY LTDGWO2020-04-03
09349797002561StarPoreANATOMICS PTY LTDGWO2020-04-03
09349797000208StarPoreANATOMICS PTY LTDGWO2020-01-08
09349797000222StarPoreANATOMICS PTY LTDGWO2020-01-08
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
08809416061665Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14
08809416061672Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14