Patella Drill Guide – Corentec 26 4240-4226

GUDID 09421028119795

A reusable surgical instrument intended to be used during an orthopaedic surgical procedure

ENZTEC LIMITED

Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device ID09421028119795
NIH Device Record Key5f09eb80-a6b0-45d9-b9dd-7cd6828d6867
Commercial Distribution StatusIn Commercial Distribution
Brand NamePatella Drill Guide – Corentec 26
Version Model Number4240-4226
Catalog Number4240-4226
Company DUNS592616445
Company NameENZTEC LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109421028119795 [Primary]

FDA Product Code

FZXGuide, Surgical, Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09421028119795]

Moist Heat or Steam Sterilization


[09421028119795]

Moist Heat or Steam Sterilization


[09421028119795]

Moist Heat or Steam Sterilization


[09421028119795]

Moist Heat or Steam Sterilization


[09421028119795]

Moist Heat or Steam Sterilization


[09421028119795]

Moist Heat or Steam Sterilization


[09421028119795]

Moist Heat or Steam Sterilization


[09421028119795]

Moist Heat or Steam Sterilization


[09421028119795]

Moist Heat or Steam Sterilization


[09421028119795]

Moist Heat or Steam Sterilization


[09421028119795]

Moist Heat or Steam Sterilization


[09421028119795]

Moist Heat or Steam Sterilization


[09421028119795]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-07
Device Publish Date2025-07-30

Devices Manufactured by ENZTEC LIMITED

09421028110624 - Enztec Femoral Impactor - DJO2026-02-09 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028110631 - DJO Femoral Impactor Head2026-02-09 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028112536 - Enztec Classic OCI - Trinket 5/16-24 UNF-022026-02-09 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421028113540 - Enztec Classic OCI - Trinket 3/8-16 UNC-012026-02-09 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421028113557 - Enztec Classic OCI - Trinket 5/16-24 UNF-012026-02-09 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421028113571 - Enztec Classic OCI - Trinket 3/8-24 UNF-012026-02-09 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421038410516 - ATTUNE FEMORAL IMPACTOR2026-02-09 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421038410523 - ATTUNE FEMORAL IMPACTOR HEAD2026-02-09 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.