Home GUDID 09421038412237 KA Femoral Alignment Guide
Primary DI 09421038412237
Brand KA Femoral Alignment Guide
Company ENZTEC LIMITED
Model 293-777
Catalog number 293-777
Device description A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
Published 2026-06-24
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name FZX Guide, Surgical, Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FZX Guide, Surgical, Instrument General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 09421038412237 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 09421038412237 09421038412237 9421038412237
GMDN Terms# Term, Definition table Term Definition Orthopaedic prosthesis implantation positioning instrument, reusable A 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 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 09421028119184 Enztec Partial Knee Femoral Impactor - Angled Arm 4240-3301 4240-3301 2026-10-07 09421028119191 Enztec Partial Knee Femoral Impactor with Slap Hammer - Angled Arm 4240-3302 4240-3302 2026-10-07 09421028110853 Tensioner, AP Sizer 2120.00.000 2120.00.000 2026-07-30 09421028110877 Tensioner, Balancer 2118.00.000 2118.00.000 2026-07-30 09421028110884 Tensioner, Distractor 2119.00.000 2119.00.000 2026-07-30 09421038412244 KA Femoral Alignment Guide - Medial Paddle 293-778 293-778 2026-06-24 09421038412251 KA Femoral Alignment Guide - Lateral Paddle 293-779 293-779 2026-06-24 09421038412268 KA Femoral Alignment Guide - Fan 293-780 293-780 2026-06-24 09421038412275 KA Femoral Alignment Guide – IM Guide 293-781 293-781 2026-06-24 09421038412282 KA Femoral Alignment Guide – Pin Guide Connector 293-782 293-782 2026-06-24 09421038413159 Reamer, Acetabular, 36mm Full 5900-RF36 5900-RF36 2026-04-16 09421038413166 Reamer, Acetabular, 37mm Full 5900-RF37 5900-RF37 2026-04-16 09421038413173 Reamer, Acetabular, 38mm Full 5900-RF38 5900-RF38 2026-04-16 09421038413180 Reamer, Acetabular, 39mm Full 5900-RF39 5900-RF39 2026-04-16 09421038413197 Reamer, Acetabular, 40mm Full 5900-RF40 5900-RF40 2026-04-16 09421038413203 Reamer, Acetabular, 41mm Full 5900-RF41 5900-RF41 2026-04-16 09421038413210 Reamer, Acetabular, 42mm Full 5900-RF42 5900-RF42 2026-04-16 09421038413227 Reamer, Acetabular, 43mm Full 5900-RF43 5900-RF43 2026-04-16 09421038413234 Reamer, Acetabular, 44mm Full 5900-RF44 5900-RF44 2026-04-16 09421038413241 Reamer, Acetabular, 45mm Full 5900-RF45 5900-RF45 2026-04-16
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