ENZTEC LIMITED

Address:3/17 PRINT PLACE, MIDDLETON,CHRISTCHURCH Canterbury,NZ

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Tray, Surgical, Instrument (FSM) (2) Guide, Surgical, Instrument (FZX) (1) Intervertebral Fusion Device With Bone Graft, Lumbar (MAX) (1)

Premarket Exempt

No Yes

Clear

CONDUIT LLIF Squid Blade - 26mm - 09421028116848 Catalog Number : LET30340T

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

Device Class : 2

Duns Number: 592616445

Premarket Exempt : No

Product Code : MAX

Prescription Use : No

Device Count : 1

Conduit LLIF Auxiliary Inserter Case - 09421028117180 Catalog Number : LEC00120C

Device Description : Tray/case used to hold other medical devices

Device Class : 1

Duns Number: 592616445

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Conduit LLIF Auxiliary Inserter Case Lid - 09421028117197 Catalog Number : LEC00110C

Device Description : Tray/case used to hold other medical devices

Device Class : 1

Duns Number: 592616445

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Enztec Premium Patella Saw Guide - 8-10mm - 09421028117722 Catalog Number : 4240-4312

Device Description : A reusable manual surgical instrument intended to be used during an orthopaedic A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure

Device Class : 1

Duns Number: 592616445

Premarket Exempt : Yes

Product Code : FZX

Prescription Use : No

Device Count : 1

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