FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867324923
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-9673-30T
Catalog number
AR-9673-30T
Device description
DEFECT GAUGE, Ø30MM GRAFT THICKNESS LEG
Published
2020-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00888867324923PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867324923008888673249238888673249230888867324923

GMDN Terms#

Term, Definition table
TermDefinition
Glenoid defect sizerA manual orthopaedic surgical instrument intended to be placed on the surface of a defective glenoid fossa to measure the angle (slope) of its bone defect for selection of an appropriately-sized glenoid reamer and/or prosthesis (not included) prior to glenoid repair/replacement. It is intended to be locked into a holder (not included) and has two arms of different lengths for angle measurement; it is available in various arm lengths. This is a reusable 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
Premarket exempt
true
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
00888867498105Arthrex®AR-3210-0037AR-3210-00372026-07-31
00888867532236Arthrex®AR-S7500-030-260-SAR-S7500-030-260-S2026-07-31
00888867532243Arthrex®AR-S7500-030-360-SAR-S7500-030-360-S2026-07-31
00888867532250Arthrex®AR-S7500-040-260-SAR-S7500-040-260-S2026-07-31
00888867532267Arthrex®AR-S7500-040-360-SAR-S7500-040-360-S2026-07-31
00888867532274Arthrex®AR-S7500-050-260-SAR-S7500-050-260-S2026-07-31
00888867544819Arthrex®AR-S7510-030-260AR-S7510-030-2602026-07-31
00888867544826Arthrex®AR-S7510-040-260AR-S7510-040-2602026-07-31
00888867544833Arthrex®AR-S7510-050-260AR-S7510-050-2602026-07-31
00888867544840Arthrex®AR-S7563-030-260AR-S7563-030-2602026-07-31
00888867544857Arthrex®AR-S7563-030-360AR-S7563-030-3602026-07-31
00888867544864Arthrex®AR-S7570-030-260AR-S7570-030-2602026-07-31
00888867544871Arthrex®AR-S7570-030-360AR-S7570-030-3602026-07-31
00888867544888Arthrex®AR-S7570-040-260AR-S7570-040-2602026-07-31
00888867544895Arthrex®AR-S7570-040-360AR-S7570-040-3602026-07-31
00888867572010Arthrex®AR-S7500-000-000WAR-S7500-000-000W2026-07-31
00888867572034Arthrex®AR-S7500-100-000WAR-S7500-100-000W2026-07-31
00888867572041Arthrex®AR-S7500-100-000FAR-S7500-100-000F2026-07-31
00888867571129Arthrex®ABS-1981-20SABS-1981-20S2026-07-29
00888867020498Arthrex®AR-1648AR-16482018-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150083473Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-08-03
B382SD480033220Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD480090Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD4834330Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD493760Surgical DirectSurgical Direct, Inc.LXH2026-08-03
00190776407391MillenniumAvalign Technologies, Inc.LXH2026-07-31
00840606191579Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191630Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191647Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191678Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191685Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191692Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191708Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191722Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191739Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191777Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191920Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191937Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191968Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191999Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00888867532236Arthrex®ARTHREX, INC.LXH2026-07-31
00888867532243Arthrex®ARTHREX, INC.LXH2026-07-31
00888867532250Arthrex®ARTHREX, INC.LXH2026-07-31
00888867532267Arthrex®ARTHREX, INC.LXH2026-07-31
00888867532274Arthrex®ARTHREX, INC.LXH2026-07-31
00888867544819Arthrex®ARTHREX, INC.LXH2026-07-31
00888867544826Arthrex®ARTHREX, INC.LXH2026-07-31
00888867544833Arthrex®ARTHREX, INC.LXH2026-07-31
00888867544840Arthrex®ARTHREX, INC.LXH2026-07-31
00888867544857Arthrex®ARTHREX, INC.LXH2026-07-31