FDA.reportPublic FDA data

Invictus Power FT, 110in-lb/12.4Nm

Primary DI
00850078396143
Brand
Invictus Power FT, 110in-lb/12.4Nm
Company
Eca Medical Instruments
Model
228-TXRX-004
Catalog number
228-TXRX-004
Published
2026-01-05
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

Product Codes#

Code, Name table
CodeName
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850078396143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850078396143008500783961438500783961430850078396143

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
00889024709164CANNULATED 1.5MM HEX DRIVERZimmer, Inc.HWE2026-10-19
00889024709171CANNULATED 2.0MM HEX DRIVERZimmer, Inc.HWE2026-10-19
00810111227872PinTreace Medical Concepts, Inc.HWE2026-10-16
00763000786458CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-15
00810111228541Drill TackTreace Medical Concepts, Inc.HWE2026-10-15
00810111227971PinTreace Medical Concepts, Inc.HWE2026-10-12
00810111227988PinTreace Medical Concepts, Inc.HWE2026-10-12
03700879515687Airlock®NOVASTEPHWE2026-08-25
08800038061286EZXIMEDICOM CO., LTD.HWE2026-08-25
00850083430108SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWE2026-08-17
00850083430122SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWE2026-08-17
00850083430139SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWE2026-08-17
00193982616472ORTHOPEDIC MANUAL SURGICAL INSTRUMENTGLOBUS MEDICAL, INC.HWE2026-08-14
10888857596719Xia® 3VB Spine LLCHWE2026-05-12
10888857596726Xia® 3VB Spine LLCHWE2026-05-12
10888857596733Xia® 3VB Spine LLCHWE2026-05-12
10888857578135Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578142Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578159Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578166Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578210Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578227Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578234Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578241Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578760Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578784Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578807Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578821Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578845Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578852Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20