FDA.reportPublic FDA data

NA

Primary DI
07613154732173
Brand
NA
Company
Stryker Leibinger GmbH & Co. KG
Model
92-51108
Catalog number
92-51108
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
07613154732173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613154732173076131547321737613154732173

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
Length8Millimeter

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
07613154731800NA92-1592392-159232017-01-11
07613154732685NA92-1592192-159212017-01-11
04546540256805NA62-0053462-005342016-10-19
04546540356529NA60-1605060-160502016-08-24
04546540356628NA62-0030262-003022016-12-08
07613154185443NA62-0044162-004412016-12-08
07613252313069DELTA70-9200970-920092015-09-24
07613252444220DELTA70-9200670-920062015-09-24
07613252444244DELTA70-9200370-920032015-09-24
07613327090123NA62-2014962-201492016-10-19
07613327090192NA62-2013962-201392016-10-19
07613327123340Delta70-9205670-920562015-09-24
07613327123364Delta70-9205570-920552015-09-24
04546540366788NA62-2052062-205202016-10-19
04546540391391NA62-0020862-002082016-12-08
07613252727002DELTA70-9204770-920472015-09-24
07613252286578FLUOROMAP6006-600-0006006-600-0002025-01-28
07613327542202N/A81-8007081-800702023-05-11
07613327542219N/A6003-700-3006003-700-3002023-05-11
07613327542363N/A6003-710-3006003-710-3002023-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841307136378Simply Iconic™ ImplantIMPLANT DIRECT SYBRON MANUFACTURING LLCDZE2026-10-26
10841307136385Simply Iconic™ ImplantIMPLANT DIRECT SYBRON MANUFACTURING LLCDZE2026-10-26
10841307136392Simply Iconic™ ImplantIMPLANT DIRECT SYBRON MANUFACTURING LLCDZE2026-10-26
10841307136408Simply Iconic™ ImplantIMPLANT DIRECT SYBRON MANUFACTURING LLCDZE2026-10-26
10841307136415Simply Iconic™ ImplantIMPLANT DIRECT SYBRON MANUFACTURING LLCDZE2026-10-26
08809984970284S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970291S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970307S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970314S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970345S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970352S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970369S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970376S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970390S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970406S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970000S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970017S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970024S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970031S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970048S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970055S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970062S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970079S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970086S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970093S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970109S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970116S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970123S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970130S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970147S-PlantIDIS CO.,LTDDZE2026-10-20