FDA.reportPublic FDA data

NA

Primary DI
04546540435606
Brand
NA
Company
Stryker Leibinger GmbH & Co. KG
Model
51-17112
Catalog number
51-17112
Device description
BONE ANCHOR SCREWS,SELF-TAPPING
Published
2015-06-16
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
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041651000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041651000STRYKER LEIBINGER SKELETAL ANCHORING SYSTEMStryker Leibinger2004-09-30DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540435606PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540435606045465404356064546540435606

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
Length12Millimeter

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
07613327480245MEDPOR5444-0-7105444-0-7102019-09-20
07613252457626MEDPOR5444-0-1105444-0-1102015-09-24
07613252457633MEDPOR5444-0-2105444-0-2102015-09-24
07613252457640MEDPOR5444-0-3105444-0-3102015-09-24
07613252457657MEDPOR5444-0-5105444-0-5102015-09-24
07613252457664MEDPOR5444-0-4105444-0-4102015-09-24
07613252457671MEDPOR5444-0-6105444-0-6102015-09-24
07613327300390MEDPOR5444-1-1105444-1-1102017-02-21
07613327300420MEDPOR5444-1-3105444-1-3102017-02-21
07613327300468MEDPOR5444-1-2105444-1-2102017-02-21
07613327300482MEDPOR5444-1-4105444-1-4102017-02-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810126046871ET III Fixture SA Regular No MountHIOSSEN, INC.DZE2026-07-14
07290112780010Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780522Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780645Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780652Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781215Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781222Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781246Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781260Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781284Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781710Dynamix Hex (Premium)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781727Dynamix Hex (Premium)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290114710565AbutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
08800070203415ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203422ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203439ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203446ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228951ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228968ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228975ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228982ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228999ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229002ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229019ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229026ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229033ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229040ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229057ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229064ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229071ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26