FDA.reportPublic FDA data

NA

Primary DI
07613327300024
Brand
NA
Company
Stryker Leibinger GmbH & Co. KG
Model
78-60100
Catalog number
78-60100
Device description
Peek customized complex-pls-craniofacial
Published
2024-04-10
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
K153248000
K190229000
K203055000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
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
07613327300024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327300024076133273000247613327300024

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, and/or cover a burr hole. 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 included with the plate.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
316153956
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327097627CranialMask Tracker6000-390-0006000-390-0002017-03-13
07613327499711N/A8900-200-2008900-200-2002023-03-23
07613327551938N/A6002-710-0506002-710-0502022-07-26
07613327620306N/A6002-810-5006002-810-5002025-10-28
07613327616118N/A6002-810-0006002-810-0002024-08-22
07613327616255N/A6002-810-3006002-810-3002024-08-15
07613327616286N/A81-8104481-810442024-08-15
07613327638189N/A6002-810-1006002-810-1002024-08-15
07613327638196N/A6002-810-2006002-810-2002024-08-15
07613327579833N/A7000015775827000015775822024-08-07
07613327576542N/A8800-100-0008800-100-0002023-04-11
07613327500530N/A8000-060-0198000-060-0192023-03-24
07613327500615N/A8000-060-0168000-060-0162023-03-23
07613327500622N/A8000-060-0148000-060-0142023-03-23
07613327500639N/A8000-060-0158000-060-0152023-03-23
07613327500646N/A8000-060-0188000-060-0182023-03-23
07613327538328Cranial Guidance Software81-8104281-810422023-03-23
07613327538410Cranial Guidance Software6000-670-3006000-670-3002023-03-23
07613327500509N/A8000-040-0178000-040-0172023-03-22
07613327500523N/A8000-040-0188000-040-0182023-03-22

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