FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867543386
Brand
Arthrex®
Company
ARTHREX, INC.
Model
76-11611S
Catalog number
76-11611S
Device description
Sixfix Strut Set SF3
Published
2026-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00888867543386PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867543386008888675433868888675433860888867543386

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
00888867386440Arthrex®AR-18827-06AR-18827-062023-01-28
00888867386457Arthrex®AR-18827-07AR-18827-072023-01-28
00888867343092Arthrex®AR-8924VNR-07SAR-8924VNR-07S2023-05-25
00888867386266Arthrex®AR-18800C-03AR-18800C-032023-01-28
00888867386303Arthrex®AR-18800C-27AR-18800C-272023-01-28
00888867387218Arthrex®AR-18800CAR-18800C2023-01-28
00888867472433Arthrex®AR-18827-54AR-18827-542025-04-09
00888867472457Arthrex®AR-18827-58AR-18827-582025-04-09
00888867498242Arthrex®AR-8935-74AR-8935-742025-04-09
00888867498259Arthrex®AR-8935-76AR-8935-762025-04-09
00888867498266Arthrex®AR-8935-78AR-8935-782025-04-09
00888867026940Arthrex®AR-2324SLMAR-2324SLM2017-02-15
00888867098169Arthrex®AR-2324SLM-1AR-2324SLM-12018-08-31
00888867614956Arthrex®AR-S8457EXCAR-S8457EXC2026-05-25
00888867531949Arthrex®AR-8827H-22SAR-8827H-22S2026-03-16
00888867531970Arthrex®AR-8827H-28SAR-8827H-28S2026-03-16
00888867531987Arthrex®AR-8827H-30SAR-8827H-30S2026-03-16
00888867532014Arthrex®AR-8827H-36SAR-8827H-36S2026-03-16
00888867134874Arthrex®AR-9104-04AR-9104-042017-02-15
00888867336506Arthrex®AR-1593-4AR-1593-42019-12-13

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Primary DI, Brand, Company table
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08032909626380ST.A.R. 90 F4CITIEFFE SRLKTT2026-03-17
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08059386747391DOLPHIXCITIEFFE SRLKTT2025-04-02
10080196692729MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10080196692866MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
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08032909624263ST.A.R. 90 F4CITIEFFE SRLKTT2024-09-11