Enztec L T D

FDA Filings

This page includes the latest FDA filings for Enztec L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3004641308
FEI Number3004641308
NameENZTEC LIMITED
Owner & OperatorENZTEC LIMITED
Contact Address3/17 Print Place, Middleton --
Christchurch NZ-CAN Canterbury 8024 NZ
Official Correspondent
  • Kate - Moorhead
  • 64-3-3480203-x
US Agent
Importing Logistics Registration
ImporterAmerican Medical Concepts
Address1525 9th Avenue Apt 3601
Seattle, WA 98101 UNITED STATES
Importer TypeINITIAL IMPORTER
Importing Logistics Registration
ImporterArthritis & Total Joint Surgeons
Address655 Blakenham Ct
Alpharetta, GA 30022 UNITED STATES
Phone1 770 3122076
Importer TypeINITIAL IMPORTER
Importing Logistics Registration
ImporterCertus Medical
Address8904 Bash St, Suite M
Indianapolis, IN 46256 UNITED STATES
Phone1 317 9652424
Importer TypeINITIAL IMPORTER
Importing Logistics Registration
ImporterGolden State Orthopaedics
Address659 W. Enterprise Ave
Clovis, CA 93619 UNITED STATES
Phone1 559 9602930
Importing Logistics Registration
Importermercury medical group
Address131 Weldon Parkway
Maryland Heights, MO 63043 UNITED STATES
Phone1 314 6162497
Importer TypeAGENT
Importing Logistics Registration
ImporterOrthoMedix
Address409 Bell Street
Piscataway, NJ 08854 UNITED STATES
Phone1 732 2829406
Importer TypeAGENT
Importing Logistics Registration
ImporterOrthoSource, LLC
Address984 Turkey Foot Road
Lexington, KY 40502 UNITED STATES
Email Addressbshrensker@twc.com
Phone1 859 3331912
Importing Logistics Registration
Importerprosser memorial health
Address723 Memorial St
Prosser, WA 99350 UNITED STATES
Email Addresswclapp@prosserhealth.org
Phone1 509 7866656
Importer TypeINITIAL IMPORTER
Importing Logistics Registration
ImporterScivance Medical
Address9307 W. 130th St. Overland Park
Overland, KS 66213 UNITED STATES
Email Addresssbarber@scivancemedical.com
Phone1 913 4861444
Importer TypeINITIAL IMPORTER
Importing Logistics Registration
ImporterSeattle Surgery Center
Address900 Terry Ave, 3rd Floor
Seattle, WA 98104 UNITED STATES
Phone1 206 3821021
Importer TypeINITIAL IMPORTER
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3/17 PRINT PLACE, MIDDLETON
CHRISTCHURCH Canterbury, 8024 NZ
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device
Company
DeviceDate
ENZTEC LIMITED
 Cup reamer handle, offset, Z/H, open 9209-13022026-03-17
ENZTEC LIMITED
 Offset drive train, open 9209-13042026-03-17
ENZTEC LIMITED
 Cup reamer handle, offset, AO, open 9209-13122026-03-17
ENZTEC LIMITED
 Offset coupling, AO 9209-13132026-03-17
ENZTEC LIMITED
 Cup reamer handle, offset, AO, locking 9209-13112026-03-17
ENZTEC LIMITED
 Handle – United 9209-13052026-03-17
ENZTEC LIMITED
 Short Offset Cover – United 9209-13072026-03-17
ENZTEC LIMITED
 Offset drive train, locking 9209-13032026-03-17
ENZTEC LIMITED
 Offset coupling, Z/H 9209-13062026-03-17
ENZTEC LIMITED
 Cup reamer handle, offset, Z/H, locking 9209-13012026-03-17
ENZTEC LIMITED
 Enztec Modular OCI XR 4251-33002026-03-09
ENZTEC LIMITED
 IM Rod – 8mm x 200mm 4240-78012026-03-09
ENZTEC LIMITED
 IM Rod – 8mm x 135mm 4240-78002026-03-09
ENZTEC LIMITED
 Dist Fem Cut Block – 1.27mm 4240-77202026-03-09
ENZTEC LIMITED
 Dist Fem Cut Block Slot Connector – 10mm 4240-77272026-03-09
ENZTEC LIMITED
 Dist Fem Cut Block Slot Connector – 9mm 4240-77262026-03-09
ENZTEC LIMITED
 Dist Fem Cut Block Slot Connector – 8mm 4240-77252026-03-09
ENZTEC LIMITED
 Dist Fem Cut Block Connector – 10mm 4240-77122026-03-09
ENZTEC LIMITED
 Dist Fem Cut Block Connector – 9mm 4240-77112026-03-09
ENZTEC LIMITED
 Dist Fem Cut Block Connector – 8mm 4240-77102026-03-09
ENZTEC LIMITED
 Sagittal Alignment Connector - Pivot with Fan 4240-77062026-03-09
ENZTEC LIMITED
 Sagittal Alignment Connector - Pivot 4240-77052026-03-09
ENZTEC LIMITED
 Adj Dist Fem Alignment Guide – Paddle 4240-77012026-03-09
ENZTEC LIMITED
 Adj Dist Fem Alignment Guide – Cartilage 4240-77002026-03-09
ENZTEC LIMITED
 Enztec Modular OCI X 4251-31012026-03-09
ENZTEC LIMITED
 Enztec Reamer 74mm - Bridgeback 4250-99742026-03-03
ENZTEC LIMITED
 Enztec Reamer 73mm - Bridgeback 4250-99732026-03-03
ENZTEC LIMITED
 Enztec Reamer 72mm - Bridgeback 4250-99722026-03-03
ENZTEC LIMITED
 Enztec Reamer 71mm - Bridgeback 4250-99712026-03-03
ENZTEC LIMITED
 Enztec Reamer 70mm - Bridgeback 4250-99702026-03-03
ENZTEC LIMITED
 Enztec Reamer 69mm - Bridgeback 4250-99692026-03-03
ENZTEC LIMITED
 Enztec Reamer 68mm - Bridgeback 4250-99682026-03-03
ENZTEC LIMITED
 Enztec Reamer 67mm - Bridgeback 4250-99672026-03-03
ENZTEC LIMITED
 Enztec Reamer 66mm - Bridgeback 4250-99662026-03-03
ENZTEC LIMITED
 Enztec Reamer 65mm - Bridgeback 4250-99652026-03-03
ENZTEC LIMITED
 Enztec Reamer 64mm - Bridgeback 4250-99642026-03-03
ENZTEC LIMITED
 Enztec Reamer 63mm - Bridgeback 4250-99632026-03-03
ENZTEC LIMITED
 Enztec Reamer 62mm - Bridgeback 4250-99622026-03-03
ENZTEC LIMITED
 Enztec Reamer 61mm - Bridgeback 4250-99612026-03-03
ENZTEC LIMITED
 Enztec Reamer 60mm - Bridgeback 4250-99602026-03-03
ENZTEC LIMITED
 Enztec Reamer 59mm - Bridgeback 4250-99592026-03-03
ENZTEC LIMITED
 Enztec Reamer 58mm - Bridgeback 4250-99582026-03-03
ENZTEC LIMITED
 Enztec Reamer 57mm - Bridgeback 4250-99572026-03-03
ENZTEC LIMITED
 Enztec Reamer 56mm - Bridgeback 4250-99562026-03-03
ENZTEC LIMITED
 Enztec Reamer 55mm - Bridgeback 4250-99552026-03-03
ENZTEC LIMITED
 Enztec Reamer 54mm - Bridgeback 4250-99542026-03-03
ENZTEC LIMITED
 Enztec Reamer 53mm - Bridgeback 4250-99532026-03-03
ENZTEC LIMITED
 Enztec Reamer 52mm - Bridgeback 4250-99522026-03-03
ENZTEC LIMITED
 Enztec Reamer 51mm - Bridgeback 4250-99512026-03-03
ENZTEC LIMITED
 Enztec Reamer 50mm - Bridgeback 4250-99502026-03-03
ENZTEC LIMITED
 Enztec Reamer 49mm - Bridgeback 4250-99492026-03-03
ENZTEC LIMITED
 Enztec Reamer 48mm - Bridgeback 4250-99482026-03-03
ENZTEC LIMITED
 Enztec Reamer 47mm - Bridgeback 4250-99472026-03-03
ENZTEC LIMITED
 Enztec Reamer 46mm - Bridgeback 4250-99462026-03-03
ENZTEC LIMITED
 Enztec Reamer 45mm - Bridgeback 4250-99452026-03-03
ENZTEC LIMITED
 Enztec Reamer 44mm - Bridgeback 4250-99442026-03-03
ENZTEC LIMITED
 Enztec Reamer 43mm - Bridgeback 4250-99432026-03-03
ENZTEC LIMITED
 Enztec Reamer 42mm - Bridgeback 4250-99422026-03-03
ENZTEC LIMITED
 Enztec Reamer 41mm - Bridgeback 4250-99412026-03-03
ENZTEC LIMITED
 Enztec Reamer 40mm - Bridgeback 4250-99402026-03-03
ENZTEC LIMITED
 Enztec Reamer 39mm - Bridgeback 4250-99392026-03-03
ENZTEC LIMITED
 Enztec Reamer 38mm - Bridgeback 4250-99382026-03-03
ENZTEC LIMITED
 Enztec Reamer 37mm - Bridgeback 4250-99372026-03-03
ENZTEC LIMITED
 Enztec Reamer 36mm - Bridgeback 4250-99362026-03-03
ENZTEC LIMITED
 Enztec Modular Anvil - Square 4200-50112026-03-02
ENZTEC LIMITED
 Enztec Modular Anvil - Offset 4200-50102026-03-02
ENZTEC LIMITED
 ATTUNE FEMORAL IMPACTOR HEAD 2548000032026-02-09
ENZTEC LIMITED
 ATTUNE FEMORAL IMPACTOR 2548000162026-02-09
ENZTEC LIMITED
 Enztec Classic OCI - Trinket 3/8-24 UNF-01 4252-20902026-02-09
ENZTEC LIMITED
 Enztec Classic OCI - Trinket 5/16-24 UNF-01 4252-20912026-02-09
ENZTEC LIMITED
 Enztec Classic OCI - Trinket 3/8-16 UNC-01 4252-20982026-02-09
ENZTEC LIMITED
 Enztec Classic OCI - Trinket 5/16-24 UNF-02 4252-20952026-02-09
ENZTEC LIMITED
 DJO Femoral Impactor Head 800-05-0362026-02-09
ENZTEC LIMITED
 Enztec Femoral Impactor - DJO 800-05-0352026-02-09
ENZTEC LIMITED
 Enztec Classic OCI - Trinket 7 /16-20 UNF-02 4252-20992026-01-14
ENZTEC LIMITED
 Enztec Classic OCI - Tornier Trinket 39910770012026-01-14
ENZTEC LIMITED
 Enztec Classic OCI – Corin Hex Driver 39910550032026-01-14
ENZTEC LIMITED
 Enztec Classic OCI - Corin Trinket 39910550012026-01-14
ENZTEC LIMITED
 Enztec Classic OCI - Corin 39910552026-01-14
ENZTEC LIMITED
 Enztec Trinket M8x1.00-03 4252-23732026-01-13
ENZTEC LIMITED
 Enztec XR Trinket 7/16-20 UNF-01 4252-24462025-12-29
ENZTEC LIMITED
 Enztec XR Trinket 3/8-24 UNF-03 4252-24452025-12-29
ENZTEC LIMITED
 Enztec XR Trinket M8X1.25-01 4252-24442025-12-29
ENZTEC LIMITED
 Offset Acetabular Shell Impactor - Enztec 1080-0-17012025-12-29
ENZTEC LIMITED
 Acetabular Shell Alignment Attachment - Enztec 1080-0-16012025-12-29
ENZTEC LIMITED
 Offset Acetabular Shell Impactor Trinket - Enztec 1080-0-15022025-12-29
ENZTEC LIMITED
 Offset Acetabular Shell Impactor Hex Driver - Enztec 1080-0-15012025-12-29
ENZTEC LIMITED
 UNIVERSAL ACETABULAR OFFSET REAMER HANDLE PPUNZRDH2025-12-23
ENZTEC LIMITED
 UNIVERSAL ACETABULAR OFFSET REAMER COVER PPUNZRDV2025-12-23
ENZTEC LIMITED
 UNIVERSAL ACETABULAR OFFSET REAMER DRIVE TRAIN PPUNZRDT2025-12-23
ENZTEC LIMITED
 UNIVERSAL ACETABULAR OFFSET REAMER COUPLING PPUNZRDC2025-12-23
ENZTEC LIMITED
 UNIVERSAL ACETABULAR OFFSET REAMER DRIVER PPUNZTC22025-12-23
ENZTEC LIMITED
 Offset Reamer Handle 4250-74142025-12-23
ENZTEC LIMITED
 Offset Reamer Cover 4250-74132025-12-23
ENZTEC LIMITED
 Offset Reamer Drive Train 4250-74122025-12-23
ENZTEC LIMITED
 Offset Reamer Coupling – Zimmer Adapter 4250-74112025-12-23
ENZTEC LIMITED
 Enovis Straight Reamer Driver - Locking - Crossbar - Large AO 90ST.EN.AO12025-12-23
ENZTEC LIMITED
 Enovis Straight Reamer Driver - Locking - Crossbar - Hudson 90ST.EN.HU12025-12-23
ENZTEC LIMITED
 Enovis Straight Reamer Driver - Locking - Crossbar - Zimmer 90ST.EN.ZH12025-12-23
ENZTEC LIMITED
 Offset Acetabular Reamer Handle - Enztec 1080-0-18012025-12-22

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