FDA.reportPublic FDA data

2.5 - ACUTRAK 3 MICRO INSTRUMENT KIT (1027-002)

Primary DI
00857676008959
Brand
2.5 - ACUTRAK 3 MICRO INSTRUMENT KIT (1027-002)
Company
Eca Medical Instruments
Model
1027-002
Catalog number
1027-002
Published
2025-11-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
00857676008959PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857676008959008576760089598576760089590857676008959

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
084330422
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850078396440SYNQ Single-Use Instrument System(1066)106610662026-10-19
00850078396426Pecaplasty Wires First Single Use kit(1052)105210522026-09-29
00850078396433PecaPusher(1061)106110612026-09-29
00850078396457Ti-TEQ Implant Extractor(1056)105610562026-09-29
00850078396396ActivaScrew™ Cannulated COM Single-Use Accessory Kit 3.5/4.0/4.5 mm(1054)105410542026-08-18
00850078396334OSSIO Drill Bit, 5.9mm Cannulated (1058)105810582026-08-14
00850078396341OSSIO 6.0mm Cannulated Drill Bit( 1059)105910592026-08-14
00850078396358OSSIO 6.1mm Cannulated Drill Bit(1060)106010602026-08-14
00857676008546LINQ Surgery Ready Instrument SystemLQG39652024-02-16
008500783961982.2 TITAN Nail Instrument KitF15-A-2784S1047-0012026-06-23
008500783962043.0 TITAN Nail Instrument KitF15-A-2884S1047-0022026-06-23
008500783962284.0 TITAN Nail Instrument KitF15-A-8004.30S1047-0032026-06-23
008500783962352.2-4.0 TITAN Nail SizerF15-A-2084S10482026-06-23
008500783962422.2 TITAN Nail Accessory KitF15-A-2785S1049-0012026-06-23
008500783962593.0 TITAN Nail Accessory KitF15-A-2885S1049-0022026-06-23
008500783962734.0 TITAN Nail Accessory KitF15-A-8004.31S1049-0032026-06-23
00850078396303PFT Adapter, SYK, Virata, 85 in-lb (228-TXRX-006)228-TXRX-006228-TXRX-0062026-06-05
00850078396310PFT Adapter, SYK, Mariner, 105 in-lb (228-TXRX-007)228-TXRX-007228-TXRX-0072026-06-05
00857676008911IM NAIL PERCUTANEOUS DEPTH GAUGE STERILE (1043)104310432026-04-02
00850078396105IM NAIL DISPOSABLE HANDLE STERILE (1044)104410442026-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00810161901432EARP TRIAL 22x40x14 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901449EARP TRIAL 22x40x12 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901456EARP TRIAL 22x40x14 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901463EARP TRIAL 22x45x10 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901470EARP TRIAL 22x45x12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901487EARP TRIAL 22x45x14 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901494EARP TRIAL 22x45x12 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901500EARP TRIAL 22x45x14 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901692EARP TRIAL 22x50x10 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901708EARP TRIAL 22x50x12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901715EARP TRIAL 22x50x14 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901722EARP TRIAL 22x50x12 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901739EARP TRIAL 22x50x14 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00840606197007MERCURYSPINAL ELEMENTS, INC.LXH2026-10-16
00840606197014MERCURYSPINAL ELEMENTS, INC.LXH2026-10-16
00840606197021MERCURYSPINAL ELEMENTS, INC.LXH2026-10-16
00840606197038MERCURYSPINAL ELEMENTS, INC.LXH2026-10-16
05055662922622Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDLXH2026-10-16
00810161900015EARP DISC SPACER INSERTERRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15