FDA.reportPublic FDA data

LEGION Kinematic Alignment Distal Valgus Guide

Primary DI
09421028119269
Brand
LEGION Kinematic Alignment Distal Valgus Guide
Company
ENZTEC LIMITED
Model
4240-7560
Catalog number
4240-7560
Device description
A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
Published
2025-01-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FZXGuide, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09421028119269PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421028119269094210281192699421028119269

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
592616445
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09421038412237KA Femoral Alignment Guide293-777293-7772026-06-24
09421038412244KA Femoral Alignment Guide - Medial Paddle293-778293-7782026-06-24
09421038412251KA Femoral Alignment Guide - Lateral Paddle293-779293-7792026-06-24
09421038412268KA Femoral Alignment Guide - Fan293-780293-7802026-06-24
09421038412275KA Femoral Alignment Guide – IM Guide293-781293-7812026-06-24
09421038412282KA Femoral Alignment Guide – Pin Guide Connector293-782293-7822026-06-24
09421038413159Reamer, Acetabular, 36mm Full5900-RF365900-RF362026-04-16
09421038413166Reamer, Acetabular, 37mm Full5900-RF375900-RF372026-04-16
09421038413173Reamer, Acetabular, 38mm Full5900-RF385900-RF382026-04-16
09421038413180Reamer, Acetabular, 39mm Full5900-RF395900-RF392026-04-16
09421038413197Reamer, Acetabular, 40mm Full5900-RF405900-RF402026-04-16
09421038413203Reamer, Acetabular, 41mm Full5900-RF415900-RF412026-04-16
09421038413210Reamer, Acetabular, 42mm Full5900-RF425900-RF422026-04-16
09421038413227Reamer, Acetabular, 43mm Full5900-RF435900-RF432026-04-16
09421038413234Reamer, Acetabular, 44mm Full5900-RF445900-RF442026-04-16
09421038413241Reamer, Acetabular, 45mm Full5900-RF455900-RF452026-04-16
09421038413258Reamer, Acetabular, 46mm Full5900-RF465900-RF462026-04-16
09421038413265Reamer, Acetabular, 47mm Full5900-RF475900-RF472026-04-16
09421038413272Reamer, Acetabular, 48mm Full5900-RF485900-RF482026-04-16
09421038413289Reamer, Acetabular, 49mm Full5900-RF495900-RF492026-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G079PDG2000Advantage-C Ti3D, Cervical InterbodyIntelivation, LLCFZX2026-07-10
M697X07901121Silex Sacroiliac Joint Fusion SystemXtant Medical Holdings, Inc.FZX2026-07-08
00190446948063Arsenal FootTrilliant Surgical, LLCFZX2026-06-24
00190446948186Arsenal FootTrilliant Surgical, LLCFZX2026-06-24
00190446948445Arsenal FootTrilliant Surgical, LLCFZX2026-06-24
00190446948452Arsenal FootTrilliant Surgical, LLCFZX2026-06-24
09421038412237KA Femoral Alignment GuideENZTEC LIMITEDFZX2026-06-24
09421038412244KA Femoral Alignment Guide - Medial PaddleENZTEC LIMITEDFZX2026-06-24
09421038412251KA Femoral Alignment Guide - Lateral PaddleENZTEC LIMITEDFZX2026-06-24
09421038412268KA Femoral Alignment Guide - FanENZTEC LIMITEDFZX2026-06-24
09421038412275KA Femoral Alignment Guide – IM GuideENZTEC LIMITEDFZX2026-06-24
09421038412282KA Femoral Alignment Guide – Pin Guide ConnectorENZTEC LIMITEDFZX2026-06-24
03700879518701NANOVASTEPFZX2026-06-23
03700879518718NANOVASTEPFZX2026-06-23
03700879518725NANOVASTEPFZX2026-06-23
03700879518732NANOVASTEPFZX2026-06-23
08800089483440Surgical InstrumentJeil Medical CorporationFZX2026-06-10
08800089483464Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2026-06-10
008401944960013P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
008401944960183P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
008401944962543P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
008401944962613P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
008401944971763P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
008401944971833P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
008401944971903P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
008401944972063P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
00889024701526Identity® Shoulder SystemZimmer, Inc.FZX2026-06-10
00889795154538Spider Monkey Bone Transport SystemParagon 28, Inc.FZX2026-06-10
00889795154545Spider Monkey Bone Transport SystemParagon 28, Inc.FZX2026-06-10
00889795154613Spider Monkey Bone Transport SystemParagon 28, Inc.FZX2026-06-10