FDA.reportPublic FDA data

Universal Mandible AXS

Primary DI
37613327567671
Brand
Universal Mandible AXS
Company
Stryker Leibinger GmbH & Co. KG
Model
56-23506
Catalog number
56-23506
Device description
Locking screws, AXS, self-tapping
Published
2023-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZLSCREW, FIXATION, INTRAOSSEOUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZLScrew, Fixation, IntraosseousDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37613327567671PrimaryGS10
07613327567670Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3761332756767137613327567671
07613327567670076133275676707613327567670

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial bone screw, non-bioabsorbableA small, threaded rod with a slotted and/or polygonal (e.g., hexagonal) head intended to be implanted 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
Length6Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
316153956
Device count
5
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
37613154881872PINABALL6003-003-0906003-003-0902016-09-21
57613252088436TLS, Quintube663066302016-08-24
07613327465532NA92-0023292-002322019-05-03
07613327465549NA92-0023092-002302019-05-03
04546540134790NA01-0323001-032302017-01-11
04546540134974NA01-0401001-040102016-12-08
04546540134998NA01-0407001-040702016-12-08
04546540135018NA01-0410001-041002016-12-08
04546540138477NA01-0956101-095612016-12-08
04546540141514NA01-1531501-153152017-01-11
04546540143242NA01-1971501-197152016-12-08
04546540143273NA01-1973001-197302016-12-08
04546540166623NA09-0146109-014612017-01-11
04546540166630NA09-0146209-014622017-01-11
04546540215161NA37-1027237-102722016-12-08
04546540215222NA37-1041137-104112016-12-08
04546540215291NA37-1093037-109302016-12-08
04546540215413NA37-1246137-124612016-12-08
04546540217059NA41-3679241-367922016-12-08
04546540217066NA41-3679341-367932016-12-08

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08800089458967Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458974Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458981Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458998Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089459001Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
ESAM23053121STOMA®Storz am Mark GmbHDZL2025-04-30
ESAM23060091STOMA® micro-screwStorz am Mark GmbHDZL2024-01-12
ESAM23060111STOMA® micro-screwStorz am Mark GmbHDZL2024-01-12
ESAM23060131STOMA® micro-screwStorz am Mark GmbHDZL2024-01-12
ESAM23061091STOMA® micro-screwStorz am Mark GmbHDZL2024-01-12
ESAM23061111STOMA® micro-screwStorz am Mark GmbHDZL2024-01-12
ESAM23061131STOMA® micro-screwStorz am Mark GmbHDZL2024-01-12
ESAM21221001STOMA®Storz am Mark GmbHDZL2023-06-19
ESAM23053141STOMA®Storz am Mark GmbHDZL2023-06-19
ESAM23048001STOMA®Storz am Mark GmbHDZL2020-11-09
ESAM23049001STOMA®Storz am Mark GmbHDZL2020-08-27
08806390878029Jeil Bone Fixation SystemJeil Medical CorporationDZL2019-06-18
10810004515700CMF VISIONAREVISIONARE, LLCDZL2019-02-21
10810004515748CMF VISIONAREVISIONARE, LLCDZL2019-02-21
10810004515755CMF VISIONAREVISIONARE, LLCDZL2019-02-21
10810004515762CMF VISIONAREVISIONARE, LLCDZL2019-02-21
10810004515779CMF VISIONAREVISIONARE, LLCDZL2019-02-21
10810004515786CMF VISIONAREVISIONARE, LLCDZL2019-02-21