FDA.reportPublic FDA data

NA

Primary DI
04546540373991
Brand
NA
Company
Stryker Leibinger GmbH & Co. KG
Model
56-25001
Catalog number
56-25001
Device description
TEMPORARY CONDYLAR PROSTHESIS, LEFT
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NEIProsthesis, condyle, mandibular, temporary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEIProsthesis, Condyle, Mandibular, TemporaryDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133285000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133285000STRYKER TEMPORARY CONDYLAR PROSTHESISStryker2014-04-09NEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540373991PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540373991045465403739914546540373991

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
04546540678683NGENIUS6003-034-0006003-034-0002016-08-24
04546540391735NA6007-425-0006007-425-0002017-12-12
07613154481118NA81-8003781-800372016-08-24
07613327413229n/a8000-040-0018000-040-0012018-08-08
07613327631814RPS88008000008800-800-0002025-10-03
07613252196259FLUOROMAP81-8102281-810222025-01-28
07613252286622FLUOROMAP6006-600-3006006-600-3002025-01-28
07613327542202N/A81-8007081-800702023-05-11
07613327542370N/A81-8007181-800712023-05-11
07613327542998N/A81-8007281-800722023-05-11
04546540245038NA6000-005-0006000-005-0002016-08-24
04546540651563NGENIUS6000-014-0006000-014-0002016-08-24
04546540717450ORTHOMAP6003-672-0006003-672-0002016-08-24
07613252127444ORTHOMAP81-8004981-800492016-08-24
07613252355717ORTHOMAP81-8005081-800502016-08-24
07613252433538ORTHOMAP6003-672-3006003-672-3002016-08-24
07613252449089ORTHOMAP81-8005581-800552017-12-12
07613252449850ORTHOMAP81-8005681-800562017-12-12
07613252450108ORTHOMAP6007-616-1006007-616-1002017-12-12
07613252450115ORTHOMAP6007-616-3006007-616-3002017-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
37613327572088Universal Mandible AXSStryker Leibinger GmbH & Co. KGNEI2023-09-15
07613327572087Universal Mandible AXSStryker Leibinger GmbH & Co. KGNEI2023-09-15
10888118131260LEVEL ONE CMFKLS-Martin L.P.NEI2021-11-22
00888118131249LEVEL ONE CMFKLS-Martin L.P.NEI2021-11-22
00888118131256LEVEL ONE CMFKLS-Martin L.P.NEI2021-11-22
00888118131263LEVEL ONE CMFKLS-Martin L.P.NEI2021-11-22
00888118113016LEVEL ONE CMFKLS-Martin L.P.NEI2018-01-26
00888118073471LEVEL ONE CMFKLS-Martin L.P.NEI2016-03-24
00888118073488LEVEL ONE CMFKLS-Martin L.P.NEI2016-03-24
00888118073501LEVEL ONE CMFKLS-Martin L.P.NEI2016-03-24
00888118073518LEVEL ONE CMFKLS-Martin L.P.NEI2016-03-24
00888118073532LEVEL ONE CMFKLS-Martin L.P.NEI2016-03-24
00888118073570LEVEL ONE CMFKLS-Martin L.P.NEI2016-03-24
10888118073492LEVEL ONE CMFKLS-Martin L.P.NEI2016-03-24
10888118073553LEVEL ONE CMFKLS-Martin L.P.NEI2016-03-24
00841036009830"""2.4MM"" LOCKING RECON SYSTEM"BIOMET MICROFIXATION, INCNEI2015-10-11
00841036009847"""2.4MM"" LOCKING RECON SYSTEM"BIOMET MICROFIXATION, INCNEI2015-10-11
00841036091507"""2.4MM"" LOCKING RECON SYSTEM"BIOMET MICROFIXATION, INCNEI2015-10-11
34546540373985NAStryker Leibinger GmbH & Co. KGNEI2015-09-24
04546540374004NAStryker Leibinger GmbH & Co. KGNEI2015-09-24
10887587016382NASynthes GmbHNEI2015-09-14
10887587016399NASynthes GmbHNEI2015-09-14
10887587016405NASynthes GmbHNEI2015-09-14
10887587016412NASynthes GmbHNEI2015-09-14
10887587016429NASynthes GmbHNEI2015-09-14
10887587016436NASynthes GmbHNEI2015-09-14
10887587016443MatrixMANDIBLESynthes GmbHNEI2015-09-14
10887587054537NASynthes GmbHNEI2015-09-14
10887587054544NASynthes GmbHNEI2015-09-14
10887587054551NASynthes GmbHNEI2015-09-14