FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867458154
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-9095-67LS
Catalog number
AR-9095-67LS
Device description
Anti-Rotation Bar, Long, Strl
Published
2024-10-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867458154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867458154008888674581548888674581540888867458154

GMDN Terms#

Term, Definition table
TermDefinition
Bone lever/elevator, single-useA manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
131747628
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867576032Arthrex®AR-3636-REMPAR-3636-REMP2026-10-20
00888867576056Arthrex®AR-3641SP-REMPAR-3641SP-REMP2026-10-20
00888867576070Arthrex®AR-6573-1AR-6573-12026-10-20
00888867576087Arthrex®AR-6573-2AR-6573-22026-10-20
00888867568280Arthrex®AR-3210-0050-SJAR-3210-0050-SJ2026-10-16
00888867568297Arthrex®AR-3210-0051-SJAR-3210-0051-SJ2026-10-16
00888867568303Arthrex®AR-3210-0059-PKAR-3210-0059-PK2026-10-16
00888867568310Arthrex®AR-3210-0063-PKAR-3210-0063-PK2026-10-16
00888867568457Arthrex®AR-8650DS-NAR-8650DS-N2026-10-16
00888867427143Arthrex®AR-S6524-025-230CAR-S6524-025-230C2023-06-05
00888867389533Arthrex®AR-9928BCK-MISAR-9928BCK-MIS2023-05-22
00888867276086Arthrex®AR-9437-16AR-9437-162022-07-15
00888867060401Arthrex®AR-9439-16AR-9439-162018-06-02
00888867060418Arthrex®AR-9439-18AR-9439-182018-06-02
00888867060425Arthrex®AR-9441-16AR-9441-162018-06-14
00888867060432Arthrex®AR-9441-18AR-9441-182018-06-02
00888867060449Arthrex®AR-9443-16AR-9443-162018-06-14
00888867060456Arthrex®AR-9443-18AR-9443-182018-06-14
00888867060463Arthrex®AR-9445-17AR-9445-172018-06-28
00888867060470Arthrex®AR-9445-19AR-9445-192018-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10810128464151Tendon Stripper, OpenT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-10-20
10810128464168Tunnel Depth ProbeT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-10-20
10840642149838Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.LXH2026-10-20
10840642149845Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.LXH2026-10-20
B504OMBMAS90006S0BrasselerProvisionLXH2026-10-20
B504OMBMAS90007S0BrasselerProvisionLXH2026-10-20
B504OMBMAS90008S0BrasselerProvisionLXH2026-10-20
B504OMBMLS900040BrasselerProvisionLXH2026-10-20
B504OMBR2544001110BrasselerProvisionLXH2026-10-20
B504OMBR9505023020BrasselerProvisionLXH2026-10-20
B504OMBR9505023030BrasselerProvisionLXH2026-10-20
B504OMDP86011710BrasselerProvisionLXH2026-10-20
B504OMST60070031000BrasselerProvisionLXH2026-10-20
B504OMST60070031500BrasselerProvisionLXH2026-10-20
B504OMST60071031100BrasselerProvisionLXH2026-10-20
B504OMST60071041500BrasselerProvisionLXH2026-10-20
B504OMZB005901020000BrasselerProvisionLXH2026-10-20
00824846013082Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-10-19
00850078396440SYNQ Single-Use Instrument System(1066)Eca Medical InstrumentsLXH2026-10-19
00889024715295Persona Extended V/V Guide Assembly (MFS)Zimmer, Inc.LXH2026-10-19
08809986489807LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-19
00810111228671Cut GuideTreace Medical Concepts, Inc.LXH2026-10-16
00810161900305EARP, TRIAL 22X35X12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900312EARP, TRIAL 22X35X14 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900329EARP, TRIAL 22X35X12 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900336EARP, TRIAL 22X35X14 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901418EARP TRIAL 22x40x10 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901425EARP TRIAL 22x40x12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16