FDA.reportPublic FDA data

HOFFMANN

Primary DI
07613327079449
Brand
HOFFMANN
Company
Stryker GmbH
Model
5029-8-400
Catalog number
5029-8-400
Device description
Connecting Rod
Published
2018-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JECCOMPONENT, TRACTION, INVASIVE
KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
LXTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JECComponent, Traction, InvasiveOrthopedic2
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2
LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal CompositeOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327079449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327079449076133270794497613327079449

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone staple, non-adjustable, non-sterileA non-sterile, non-bioabsorbable, implantable device designed to be inserted into fractured bone to achieve fixation and repair; the device may also be used to attach/secure structures (e.g., ligaments/tendons) to bone, or to reduce/cease bone growth in skeletal deformities (e.g., by being implanted across epiphysial cartilage). It is typically a curved or U-shaped device made of metal alloy material, and is not adjustable after it has been applied. Disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length400Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
481999654
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327414127PANGEA706408S706408S2023-06-13
07613327415582PANGEA706407S706407S2023-06-13
07613327416138PANGEA706406S706406S2023-06-13
07613327539585PANGEA706444S706444S2023-06-13
07613327541731PANGEA703551S703551S2023-06-13
07613327541748PANGEA703555S703555S2023-06-13
07613154969357VARIAX45-35015S45-35015S2020-09-24
04546540195913NA1806-0083S1806-0083S2020-04-07
04546540195937NA1806-0085S1806-0085S2020-04-07
04546540195951NA1806-0090S1806-0090S2020-04-07
04546540195975NA1806-0093S1806-0093S2020-04-07
07613154633326NA45-20011S45-20011S2018-09-24
07613154633432NA45-30011S45-30011S2018-09-24
07613154665891NA45-20001S45-20001S2018-09-24
07613154665907NA45-20004S45-20004S2018-09-24
07613154665914NA45-30001S45-30001S2018-09-24
07613154665921NA45-30004S45-30004S2018-09-24
07613327083286AXSOS705077S705077S2016-09-24
07613327083323AXSOS705078S705078S2016-09-24
07613327083330AXSOS705031S705031S2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327616859HOFFMANN LRFStryker GmbHKTT2026-07-23
07613327616880HOFFMANN LRFStryker GmbHKTT2026-07-23
07613327616835HOFFMANN LRFStryker GmbHKTT2026-07-21
07613327616866HOFFMANN LRFStryker GmbHKTT2026-07-21
10888867544571Arthrex®ARTHREX, INC.KTT2026-03-13
00887868549236MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549243MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549250MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549267MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549274MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549281MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549298MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549304MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549311MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549328MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549335MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549342MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549359MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549366MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549373MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549380MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868544699SMOOTH PEGBiomet Orthopedics, LLCLXT2022-09-07
00887868544705SMOOTH PEGBiomet Orthopedics, LLCLXT2022-09-07
00887868544712SMOOTH PEGBiomet Orthopedics, LLCLXT2022-09-07
00887868544729SMOOTH PEGBiomet Orthopedics, LLCLXT2022-09-07
00887868544736SMOOTH PEGBiomet Orthopedics, LLCLXT2022-09-07
00887868544743SMOOTH PEGBiomet Orthopedics, LLCLXT2022-09-07
00887868544750SMOOTH PEGBiomet Orthopedics, LLCLXT2022-09-07
00887868544767SMOOTH PEGBiomet Orthopedics, LLCLXT2022-09-07
00887868544774SMOOTH PEGBiomet Orthopedics, LLCLXT2022-09-07