FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867543690
Brand
Arthrex®
Company
ARTHREX, INC.
Model
78-00010
Catalog number
78-00010
Device description
Reduction Strut, Short
Published
2026-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200123000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200123000Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC2020-09-22KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867543690PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867543690008888675436908888675436900888867543690

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system noninvasive component, single-useA noninvasive structural component of an external orthopaedic fixation system intended for bone/joint fracture stabilization in conjunction with an invasive bone pin (not included). It is in the form of a full or partial ring, rod (e.g., straight, curved, telescopic), plate, or connector (e.g., screw, bolt, nut, hinge, coupling, fastener); it is not a surgical instrument. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)934-4404complaints@arthrex.com

Regulatory Flags#

DUNS number
131747628
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
00888867050037Arthrex®AR-8933L-14SAR-8933L-14S2017-08-31
00888867050051Arthrex®AR-8933L-16SAR-8933L-16S2017-08-31
00888867050075Arthrex®AR-8933L-18SAR-8933L-18S2017-08-31
00888867051324Arthrex®AR-8940-16SAR-8940-16S2017-03-03
00888867051348Arthrex®AR-8940-18SAR-8940-18S2017-03-03
00888867051386Arthrex®AR-8940-22SAR-8940-22S2017-03-03
00888867051447Arthrex®AR-8940-28SAR-8940-28S2017-03-03
00888867051485Arthrex®AR-8940-32SAR-8940-32S2017-03-03
00888867051560Arthrex®AR-8940-40SAR-8940-40S2017-03-03
00888867051584Arthrex®AR-8940-42SAR-8940-42S2017-03-03
00888867053304Arthrex®AR-8945-22FTSAR-8945-22FTS2017-08-31
00888867053496Arthrex®AR-8945-30PTSAR-8945-30PTS2017-08-31
00888867053533Arthrex®AR-8945-32PTSAR-8945-32PTS2017-08-31
00888867053649Arthrex®AR-8945-36PTSAR-8945-36PTS2017-08-31
00888867053687Arthrex®AR-8945-38PTSAR-8945-38PTS2017-08-31
00888867053724Arthrex®AR-8945-40PTSAR-8945-40PTS2017-08-31
00888867053755Arthrex®AR-8945-45FTSAR-8945-45FTS2017-08-31
00888867053816Arthrex®AR-8945-50PTSAR-8945-50PTS2017-08-31
00888867053854Arthrex®AR-8945-55PTSAR-8945-55PTS2017-08-31
00888867053892Arthrex®AR-8945-60PTSAR-8945-60PTS2017-08-31

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Primary DI, Brand, Company table
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