FDA.reportPublic FDA data

NA

Primary DI
07613252288190
Brand
NA
Company
Stryker Leibinger GmbH & Co. KG
Model
12-01530S
Catalog number
12-01530S
Device description
2 HOLE PLATES(3) SELF DRILLING SCREW(6)
Published
2015-06-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
K120352000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120352000STRYKER QUIKFLAP STERILE PROCEDURE PACKStryker2012-06-11GWO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613252288190PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613252288190076132522881907613252288190

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial fixation plate, non-bioabsorbableA small, implantable sheet of firm material that is attached with screws to fractured craniofacial bone (including the maxilla and/or mandible), to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material cannot be chemically degraded or absorbed by natural body processes [includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre]. The device may also be used for craniofacial reconstructive procedures (e.g., to treat congenital malformations), endobrow fixation, or craniotomy flap fixation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
316153956
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04546540001122COLORADOE1033E10332016-08-24
04546540001139COLORADOE1034E10342016-08-24
04546540001153COLORADOE1035E10352016-08-24
04546540001177COLORADOE1036E10362016-08-24
04546540001191COLORADOE1037E10372016-08-24
04546540001214COLORADOE1133E11332016-08-24
04546540001221COLORADOE1134E11342016-08-24
04546540001238COLORADOE1135E11352016-08-24
04546540001245COLORADOE1136E11362016-08-24
04546540001252COLORADOE1137E11372016-08-24
04546540001269COLORADOE1173E11732016-08-24
04546540001283COLORADOE1174E11742016-08-24
04546540001306COLORADOE1175E11752016-08-24
04546540001313COLORADOE1175AE1175A2016-08-24
04546540001320COLORADOE1176E11762016-08-24
04546540001344COLORADOE1177E11772016-08-24
04546540001405COLORADOE1455E14552016-08-24
04546540004093COLORADON103AN103A2016-08-24
04546540004116COLORADON104AN104A2016-08-24
04546540004130COLORADON110AN110A2016-08-24

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Primary DI, Brand, Company table
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