CONDUIT ATP Cobb 18mm 24° Right 287361242

GUDID 09421028118415

Intended to be used for the insertion of spinal implants into the spinal space during total artificial disc replacement surgery.

ENZTEC LIMITED

Orthopaedic implant inserter/extractor, reusable
Primary Device ID09421028118415
NIH Device Record Keyccf0f45e-331f-4781-9f2e-617c47f21886
Commercial Distribution StatusIn Commercial Distribution
Brand NameCONDUIT ATP Cobb 18mm 24° Right
Version Model Number287361242
Catalog Number287361242
Company DUNS592616445
Company NameENZTEC LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
GS109421028118415 [Primary]

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09421028118415]

Moist Heat or Steam Sterilization


[09421028118415]

Moist Heat or Steam Sterilization


[09421028118415]

Moist Heat or Steam Sterilization


[09421028118415]

Moist Heat or Steam Sterilization


[09421028118415]

Moist Heat or Steam Sterilization


[09421028118415]

Moist Heat or Steam Sterilization


[09421028118415]

Moist Heat or Steam Sterilization


[09421028118415]

Moist Heat or Steam Sterilization


[09421028118415]

Moist Heat or Steam Sterilization


[09421028118415]

Moist Heat or Steam Sterilization


[09421028118415]

Moist Heat or Steam Sterilization


[09421028118415]

Moist Heat or Steam Sterilization


[09421028118415]

Moist Heat or Steam Sterilization


[09421028118415]

Moist Heat or Steam Sterilization


[09421028118415]

Moist Heat or Steam Sterilization


[09421028118415]

Moist Heat or Steam Sterilization


[09421028118415]

Moist Heat or Steam Sterilization


[09421028118415]

Moist Heat or Steam Sterilization


[09421028118415]

Moist Heat or Steam Sterilization


[09421028118415]

Moist Heat or Steam Sterilization


[09421028118415]

Moist Heat or Steam Sterilization


[09421028118415]

Moist Heat or Steam Sterilization


[09421028118415]

Moist Heat or Steam Sterilization


[09421028118415]

Moist Heat or Steam Sterilization


[09421028118415]

Moist Heat or Steam Sterilization


[09421028118415]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-12
Device Publish Date2023-12-04

Devices Manufactured by ENZTEC LIMITED

09421028117494 - 3.5mm Hex Driver Shaft – AO – 250mm2025-12-15 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
09421028117500 - 4.0mm Hex Driver Shaft – AO2025-12-15 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
09421028117517 - 6.0mm Hex Driver Shaft – Zimmer2025-12-15 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
09421038410912 - 3.5mm Hex Driver Shaft – AO – 100mm2025-12-15 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
09421038410509 - Drill Pin Driver – AO2025-11-21 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
09421028119054 - Neck Holder2025-10-06 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119061 - Base2025-10-06 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119078 - Head Holder2025-10-06 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.