FDA.reportPublic FDA data

NA

Primary DI
34546540373985
Brand
NA
Company
Stryker Leibinger GmbH & Co. KG
Model
56-25000
Catalog number
56-25000
Device description
Fixation Screws f. Condylar Prosthesis
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
MPLMandibular condyle prosthesis
NEIProsthesis, condyle, mandibular, temporary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MPLMandibular Condyle ProsthesisDental3
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
34546540373985PrimaryGS10
04546540373984Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3454654037398534546540373985
04546540373984045465403739844546540373984

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head intended to be implanted or inserted short-term in craniofacial bone (including the maxilla and/or mandible) for fracture fixation by direct interfragmentary stabilization of bone or by screwing plates in place; it may also be intended for transplanted bone fixation. It may be self-drilling/self-tapping and is made of a material that is not chemically degraded or absorbed via natural body processes [e.g., implant grade metal such as titanium (Ti)]. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, craniotomy flap fixation, bone augmentation procedures.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length4.6Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
316153956
Device count
2
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
07613327602241NA470000747000072026-07-17
07613327602258NA474100247410022026-07-17
07613327602272NA476007347600732026-07-17
07613327602289NA476100147610012026-07-17
07613327602296NA470020347002032026-07-17
07613327602302NA470000647000062026-07-17
07613327602319NA474100147410012026-07-17
07613327602326NA470000847000082026-07-17
07613327602333NA474100347410032026-07-17
07613327602340NA476100747610072026-07-17
07613327602364NA476004347600432026-07-17
07613327602401NA474100447410042026-07-17
07613327602418NA470020447002042026-07-17
07613327643336NA474100547410052026-07-17
07613327643343NA476101147610112026-07-17
07613327643350NA476101347610132026-07-17
07613327643367NA476101447610142026-07-17
07613327643374NA476100247610022026-07-17
07613327643381NA476100647610062026-07-17
07613327643398NA476100447610042026-07-17

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
04546540373991NAStryker 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