FDA.reportPublic FDA data

NA

Primary DI
07613252288220
Brand
NA
Company
Stryker Leibinger GmbH & Co. KG
Model
12-01536S
Catalog number
12-01536S
Device description
2 H. PLATES(2) 20mm BHC(1) SD SCREW(10)
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
07613252288220PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613252288220076132522882207613252288220

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
07613252578208NA78-2102878-210282015-07-03
07613252578215NA78-2002878-200282015-07-03
07613252578222NA78-2002078-200202015-07-03
07613252578239NA78-2102078-210202015-07-03
07613252599647NA78-3002078-300202015-07-03
07613252599654NA78-3002878-300282015-07-03
07613252599661NA78-3102078-310202015-07-03
07613252599678NA78-3102878-310282015-07-03
07613327392715DELTA70-7620170-762012018-06-07
04546540364883NA50-1290050-129002023-02-13
07613327369489AXS62-1217862-121782019-09-11
04546540246332NA60-1010460-101042016-08-24
04546540246356NA60-1010860-101082016-08-24
04546540246387NA60-1011260-101122016-08-24
04546540256805NA62-0053462-005342016-10-19
04546540258991NA62-1740162-174012016-10-19
04546540274175NA64-0010564-001052016-12-08
04546540274250NA64-0013264-001322017-01-11
04546540356758NA64-0024264-002422016-12-08
04546540356765NA64-0024364-002432016-12-08

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