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Data / Medical devices / New Zealand / Enztec Limited

Enztec Limited: FDA-registered device maker in CHRISTCHURCH Canterbury, New Zealand, 5 510(k) clearances

Enztec Limited is registered with the FDA (registration 3004641308) in CHRISTCHURCH Canterbury, New Zealand. It lists 36 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 1, 2023. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Enztec Limited
FDA registration number
3004641308
Address
3/17 Print Place, Middleton, CHRISTCHURCH Canterbury, New Zealand, 8024
Owner or operator
ENZTEC LIMITED (9084846)
Roles
Contract manufacturer, Manufacturer
First device listed
March 24, 2006
Registered through
2027

Devices it lists

DeviceProduct codeClassRoleSource
Blade, Saw, General & Plastic Surgery, SurgicalGFA1Manufactureraccessdata.fda.gov
CaliperKTZ1Manufactureraccessdata.fda.gov
ClampHXD1Contract manufacturer, Manufactureraccessdata.fda.gov
ExtractorHWB1Manufactureraccessdata.fda.gov
Gauge, DepthHTJ1Contract manufacturer, Manufactureraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Contract manufacturer, Manufactureraccessdata.fda.gov
Hook, BoneKIK1Contract manufacturer, Manufactureraccessdata.fda.gov
ImpactorHWA1Contract manufacturer, Manufactureraccessdata.fda.gov
Instrument, CompressionHWN1Manufactureraccessdata.fda.gov
Instrument, Cutting, OrthopedicHTZ1Contract manufactureraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE1Contract manufacturer, Manufactureraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/AttachmentHSZ1Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Contract manufacturer, Manufactureraccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Manufactureraccessdata.fda.gov
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/PolymerKWZ2Contract manufactureraccessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedKWY2Contract manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedLZO2Contract manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, CementedJDI2Contract manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedLPH2Contract manufactureraccessdata.fda.gov
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerHRY2Contract manufactureraccessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH2Contract manufactureraccessdata.fda.gov
Prosthesis, Shoulder, Hemi-, Humeral, Metallic UncementedHSD2Contract manufactureraccessdata.fda.gov
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer CementedKWT2Contract manufactureraccessdata.fda.gov
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, CementedPAO2Contract manufactureraccessdata.fda.gov
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedKWS2Contract manufactureraccessdata.fda.gov
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, UncementedMBF2Contract manufactureraccessdata.fda.gov
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-ConstrainedPKC2Contract manufactureraccessdata.fda.gov
RaspHTR1Manufactureraccessdata.fda.gov
ReamerHTO1Contract manufacturer, Manufactureraccessdata.fda.gov
RetractorGAD1Contract manufacturer, Manufactureraccessdata.fda.gov
ScrewdriverHXX1Contract manufacturer, Manufactureraccessdata.fda.gov
Shoulder Prosthesis, Reverse ConfigurationPHX2Contract manufactureraccessdata.fda.gov
Table And Attachments, Operating-RoomBWN1Manufactureraccessdata.fda.gov
TemplateHWT1Contract manufacturer, Manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 1, 2023K232014CONDUIT™ ATP InsertersMAXSubstantially EquivalentEnztec Limitedaccessdata.fda.gov
June 27, 2023K230876RI.KNEE Adjustable Tibia Cut GuideOLOSubstantially EquivalentEnztec Limitedaccessdata.fda.gov
January 5, 2023K223671CONDUIT LLIF Straight InsertersMAXSubstantially EquivalentEnztec Limitedaccessdata.fda.gov
June 28, 2022K220449DePuy CONDUIT LLIF SQUID InserterMAXSubstantially EquivalentEnztec Limitedaccessdata.fda.gov
November 1, 2021K212823DePuy CONDUIT LLIF Angled InsertersMAXSubstantially EquivalentEnztec Limitedaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
August 16, 201984217Class IITerminatedREF 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.accessdata.fda.gov

Compare with other makers

Updated September 1, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.