FDA.reportPublic FDA data

NA

Primary DI
07613154274765
Brand
NA
Company
Stryker Leibinger GmbH & Co. KG
Model
92-51116
Catalog number
92-51116
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
07613154274765PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613154274765076131542747657613154274765

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
Length16Millimeter

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
07613327711578NA92-5577292-557722026-09-24
07613327711585NA92-5577392-557732026-09-24
07613327711592NA92-5577192-557712026-09-24
07613327711608NA92-5577092-557702026-09-24
04546540337818DELTA70-7132470-713242016-08-24
04546540337825DELTA70-7132670-713262016-08-24
04546540337900DELTA70-7182270-718222016-08-24
07613327097627CranialMask Tracker6000-390-0006000-390-0002017-03-13
07613327499711N/A8900-200-2008900-200-2002023-03-23
07613327551938N/A6002-710-0506002-710-0502022-07-26
07613327620306N/A6002-810-5006002-810-5002025-10-28
07613327616118N/A6002-810-0006002-810-0002024-08-22
07613327616255N/A6002-810-3006002-810-3002024-08-15
07613327616286N/A81-8104481-810442024-08-15
07613327638189N/A6002-810-1006002-810-1002024-08-15
07613327638196N/A6002-810-2006002-810-2002024-08-15
07613327579833N/A7000015775827000015775822024-08-07
07613327576542N/A8800-100-0008800-100-0002023-04-11
07613327500530N/A8000-060-0198000-060-0192023-03-24
07613327500615N/A8000-060-0168000-060-0162023-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290114712149prosthetics - AnalogCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712767prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712774prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712781prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712798prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712804prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712811prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712828prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712835prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712842prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712859prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712866prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712873prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712880prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712897prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712903prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712910prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712927prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712934prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712941prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712958prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712965prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114713009prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114713016prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114713023prosthetics - AnalogCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114713030prosthetics - AnalogCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114713047prosthetics -TransferCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114713061prosthetics -TransferCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114713078prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114713085prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06