FDA.reportPublic FDA data

Arthrex®

Primary DI
10888867544571
Brand
Arthrex®
Company
ARTHREX, INC.
Model
71-00004
Catalog number
71-00004
Device description
Strut Clip
Published
2026-03-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTYPIN, FIXATION, SMOOTH
KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
OSNSoftware for diagnosis/treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTYPin, Fixation, SmoothOrthopedic2
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2
OSNSoftware For Diagnosis/TreatmentOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190069000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190069000SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Arrowhead De, LLC2019-05-14KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888867544571PrimaryGS10
00888867544574Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088886754457110888867544571
00888867544574008888675445748888675445740888867544574

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system noninvasive component, single-useA noninvasive, non-powered structural component of an external orthopaedic fixation system intended for bone/joint treatment (typically fracture stabilization, deformity correction, or distraction), 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
6
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867272446Arthrex®AR-5566-01AR-5566-012017-08-17
00888867384866Arthrex®AR-3200-1053AR-3200-10532021-09-24
00888867338050Arthrex®ABS-4085-TPABS-4085-TP2020-07-01
00888867339941Arthrex®AR-3200-1052AR-3200-10522019-08-08
00888867389526Arthrex®AR-9928P-CPAR-9928P-CP2024-05-29
00888867425736Arthrex®AR-9928BCK-DXAR-9928BCK-DX2023-05-22
00888867101968Arthrex®AR-3600DSAR-3600DS2017-02-15
00888867038936Arthrex®AR-6068-45RAR-6068-45R2018-09-15
00888867306004Arthrex®AR-9501FTKAR-9501FTK2021-06-30
00888867430662Arthrex®AR-S7110-020U-330WAR-S7110-020U-330W2023-09-15
00888867427310Arthrex®AR-S7111-025-330WAR-S7111-025-330W2023-06-05
00888867427327Arthrex®AR-S7111-035-330WAR-S7111-035-330W2023-06-05
00888867427334Arthrex®AR-S7115-025-260WAR-S7115-025-260W2023-06-05
00888867427341Arthrex®AR-S7116-020-260WAR-S7116-020-260W2023-06-05
00888867427358Arthrex®AR-S7116-025U-330WAR-S7116-025U-330W2023-06-05
00888867427365Arthrex®AR-S7121-020-330WAR-S7121-020-330W2023-06-05
00888867427372Arthrex®AR-S7115-025-330WAR-S7115-025-330W2023-06-05
00888867427389Arthrex®AR-S7116-025-330WAR-S7116-025-330W2023-06-05
00888867427396Arthrex®AR-S7116-025-260WAR-S7116-025-260W2023-06-05
00888867427495Arthrex®AR-S7120-025-330WAR-S7120-025-330W2023-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840536824974PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536824981PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536824998PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825001PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825018PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825025PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825032PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825049PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825056PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825063PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825070PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825087PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825094PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00190776405960MillenniumAvalign Technologies, Inc.HTY2026-07-28
07613327616859HOFFMANN LRFStryker GmbHKTT2026-07-23
07613327616880HOFFMANN LRFStryker GmbHKTT2026-07-23
00190776403928MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776403935MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436025MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436032MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436049MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436056MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436063MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436070MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436087MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436094MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436100MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436117MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436124MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436131MillenniumAvalign Technologies, Inc.HTY2026-07-22