510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Enztec Limited

CHRISTCHURCH Canterbury, NZ

ENZTEC LIMITED appears in FDA device records in CHRISTCHURCH Canterbury, NZ. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
5
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 5 510(k) clearances for Enztec Limited between 2021 and 2023. The busiest year on record is 2023, with 3. The most recent is 2023, with 3.

Clearances by year, as a table
510(k) clearance decisions for Enztec Limited, by decision year
YearClearances
20211
20221
20233
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K232014CONDUIT™ ATP InsertersMAXSubstantially Equivalent
K230876RI.KNEE Adjustable Tibia Cut GuideOLOSubstantially Equivalent
K223671CONDUIT LLIF Straight InsertersMAXSubstantially Equivalent
K220449DePuy CONDUIT LLIF SQUID InserterMAXSubstantially Equivalent
K212823DePuy CONDUIT LLIF Angled InsertersMAXSubstantially Equivalent

Registered establishments

FDA registered establishments for Enztec Limited, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30046413083004641308ENZTEC LIMITED3/17 PRINT PLACE, MIDDLETON, CHRISTCHURCH Canterbury 8024 NZ2026and 25 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0612-2020REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEEThe femoral impactors have a higher than normal risk of the arm breaking. During impaction the tip of the arm may fracture and separate from the instrument. This may cause a minor delay in surgery. If not retrieved, it may cause an inflammatory response that may require revision surgery.Class IITerminated

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Enztec Limited edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of , FDA export datePage updated Source: openFDA, public domain