FDA.reportPublic FDA data

ARBOR

Primary DI
00889095530896
Brand
ARBOR
Company
GLOBUS MEDICAL, INC.
Model
2173.1302
Device description
Schanz Pin, Blunt-Tip, 4x120mm, 30mm Cancellous Thread, SS
Published
2020-03-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
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
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2
LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal CompositeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172438000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172438000ARBOR External Fixation SystemGlobus Medical, Inc.2018-01-12KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889095530896PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889095530896008890955308968890955308960889095530896

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system, single-use, non-sterileAn assembly of non-sterile devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
139105691
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889095401820ANTHEM2171.65092171.65092026-09-25
00889095401844ANTHEM2171.65112171.65112026-09-25
00889095401868ANTHEM2171.65132171.65132026-09-25
00889095401882ANTHEM2171.65152171.65152026-09-25
00889095401905ANTHEM2171.65172171.65172026-09-25
00889095401929ANTHEM2171.65192171.65192026-09-25
00889095402285ANTHEM2171.65552171.65552026-09-25
00889095402438ANTHEM2171.65702171.65702026-09-25
00889095402483ANTHEM2171.65752171.65752026-09-25
00889095402537ANTHEM2171.65802171.65802026-09-25
00889095411263ANTHEM7171.55097171.55092026-09-25
00889095411287ANTHEM7171.55117171.55112026-09-25
00889095411300ANTHEM7171.55137171.55132026-09-25
00889095411324ANTHEM7171.55157171.55152026-09-25
00889095611274ANTHEM2171.65852171.65852026-09-25
00193982003630N/A6190.00266190.00262026-08-14
00193982016340N/A6178.01676178.01672026-08-14
00193982096274ANTHEM2170.10362170.10362026-08-14
00193982096298ANTHEM2170.10382170.10382026-08-14
00193982096311ANTHEM2170.10402170.10402026-08-14

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
00885556819791UNI-CP Compression PlateSmith & Nephew, Inc.LXT2023-10-26
00885556839942Total Wrist Fusion SystemSmith & Nephew, Inc.LXT2022-12-21
00885556839959Total Wrist Fusion SystemSmith & Nephew, Inc.LXT2022-12-21
00885556839966Total Wrist Fusion SystemSmith & Nephew, Inc.LXT2022-12-21
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