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
 Enztec Trinket M8x1.25-02 4252-23712024-10-21
ENZTEC LIMITED
 Enztec Trinket 3/8-16 UNC-03 4252-23692024-10-21
ENZTEC LIMITED
 Kinematic Alignment Caliper 4240-73492024-10-21
ENZTEC LIMITED
 Enztec Trinket M8x1.25-01 4252-23682024-09-02
ENZTEC LIMITED
 Enztec Trinket 5/16-24 UNF-01 4252-23672024-09-02
ENZTEC LIMITED
 Enztec Trinket 3/8-24 UNF-03 4252-23702024-09-02
ENZTEC LIMITED
 PROCOTYL® P ENZTEC LATERAL ALIGNMENT GUIDE PPENZLAG2024-08-23
ENZTEC LIMITED
 PROCOTYL® P ENZTEC SUPINE ALIGNMENT GUIDE PPENZSAG2024-08-23
ENZTEC LIMITED
 Enztec Alignment Guide - Supine 45° - 15° 4252-22212024-08-23
ENZTEC LIMITED
 Enztec Alignment Guide - Lateral 45° - 20° 4252-22202024-08-23
ENZTEC LIMITED
 Enztec Cup Impactor Alignment Guide - Lateral 4252-20092024-08-23
ENZTEC LIMITED
 Enztec Cup Impactor Alignment Guide - Supine 4252-20082024-08-23
ENZTEC LIMITED
 Enztec XR Trinket 3/8-24 UNF-01 4252-24432024-07-18
ENZTEC LIMITED
 Enztec XR Trinket 3/8-24 UNF-02 4252-24422024-07-18
ENZTEC LIMITED
 Enztec XR Trinket 5/16-24 UNF-01 4252-24412024-07-18
ENZTEC LIMITED
 Enztec Classic OCI XR 4252-24202024-07-18
ENZTEC LIMITED
 MedEnvision Retractor 15 ME-EC00152024-07-11
ENZTEC LIMITED
 MedEnvision Retractor 14 ME-EC00142024-07-11
ENZTEC LIMITED
 MedEnvision Retractor 13 ME-EC00132024-07-11
ENZTEC LIMITED
 MedEnvision Retractor 12 ME-EC00122024-07-11
ENZTEC LIMITED
 MedEnvision Retractor 11 ME-EC00112024-07-11
ENZTEC LIMITED
 Enztec Trinket M8X1.00-02 4252-23662024-07-02
ENZTEC LIMITED
 Corentec Femoral Impactor Head 4240-31032024-06-20
ENZTEC LIMITED
 Enztec Femoral Impactor with Slap Hammer – Corentec 4240-31022024-06-20
ENZTEC LIMITED
 Enztec Trinket M8X1.00-01 4252-23642024-05-24
ENZTEC LIMITED
 Exactech Straight DA Broach Handle 4251-40802024-04-22
ENZTEC LIMITED
 Enztec Trinket M10X1.00-01 4252-23652024-03-21
ENZTEC LIMITED
 Bone Hook ME-BH00012024-03-19
ENZTEC LIMITED
 Enztec Straight Cup Impactor 4252-24002024-03-08
ENZTEC LIMITED
 PROCOTYL® P ENZTEC STRAIGHT HANDLE PPENZSTR2024-03-08
ENZTEC LIMITED
 PROCOTYL® P ENZTEC LINER IMPACTOR ADAPTER PPENZLMA2024-03-08
ENZTEC LIMITED
 Double Offset Broach Handle M2 Connection - Left 9095.11.0162024-02-16
ENZTEC LIMITED
 Double Offset Broach Handle M2 Connection - Right 9095.11.0152024-02-16
ENZTEC LIMITED
 Enztec Hohmann Narrow Long Retractor 4000-00032024-02-07
ENZTEC LIMITED
 Blunt Hohmann Retractor 4050-00682024-02-06
ENZTEC LIMITED
 Reamer Driver Lock Ring 4250-71112024-01-23
ENZTEC LIMITED
 TriVerse Locking Femoral Impactor Head 02-039-19-13012023-12-25
ENZTEC LIMITED
 TriVerse Locking Femoral Impactor 02-039-19-13002023-12-25
ENZTEC LIMITED
 Double Offset Left Woodpecker Adaptor M2 Connection 9095.11.0562023-12-13
ENZTEC LIMITED
 Double Offset Right Woodpecker Adaptor M2 Connection 9095.11.0552023-12-13
ENZTEC LIMITED
 CONDUIT ATP Cobb 22mm 36° Right 2873613642023-12-12
ENZTEC LIMITED
 CONDUIT ATP Cobb 22mm 36° Left 2873613632023-12-12
ENZTEC LIMITED
 CONDUIT ATP Cobb 22mm 24° Right 2873612442023-12-12
ENZTEC LIMITED
 CONDUIT ATP Cobb 22mm 24° Left 2873612432023-12-12
ENZTEC LIMITED
 CONDUIT ATP 6mm Spreader 36° 2873632662023-12-12
ENZTEC LIMITED
 CONDUIT ATP 6mm Spreader 24° 2873632462023-12-12
ENZTEC LIMITED
 CONDUIT ATP 4mm Spreader 36° 2873632642023-12-12
ENZTEC LIMITED
 CONDUIT ATP 4mm Spreader 24° 2873632442023-12-12
ENZTEC LIMITED
 CONDUIT ATP Cobb 18mm 36° Right 2873613622023-12-12
ENZTEC LIMITED
 CONDUIT ATP Cobb 18mm 36° Left 2873613612023-12-12
ENZTEC LIMITED
 CONDUIT ATP Cobb 18mm 24° Right 2873612422023-12-12
ENZTEC LIMITED
 CONDUIT ATP Cobb 18mm 24° Left 2873612412023-12-12
ENZTEC LIMITED
 CONDUIT ATP Trial Inserter 36° LET20236T2023-12-12
ENZTEC LIMITED
 CONDUIT ATP Trial Inserter 24° LET20224T2023-12-12
ENZTEC LIMITED
 CONDUIT ATP Implant Inserter 36° LET30336T2023-12-12
ENZTEC LIMITED
 CONDUIT ATP Implant Inserter 24° LET30324T2023-12-12
ENZTEC LIMITED
 CONDUIT ATP Inserter Hex Driver LET30401T2023-12-12
ENZTEC LIMITED
 CONDUIT ATP Handle LET30400T2023-12-12
ENZTEC LIMITED
 PROCOTYL® P ENZTEC STRIKE PLATE PPENZSTP2023-11-16
ENZTEC LIMITED
 PROCOTYL® P ENZTEC IMPACTOR HANDLE PPENZHND2023-11-16
ENZTEC LIMITED
 PROCOTYL® P ENZTEC STRAIGHT HEX DRIVER PPENZHEX2023-11-16
ENZTEC LIMITED
 PROCOTYL® P ENZTEC OFFSET HANDLE PPENZOFF2023-11-16
ENZTEC LIMITED
 Corin Anvil 4252-23212023-11-16
ENZTEC LIMITED
 PROCOTYL® P ENZTEC THREADED ADAPTER PPENZTHA2023-11-16
ENZTEC LIMITED
 Enztec Trinket M8x0.75-01 4252-23602023-11-16
ENZTEC LIMITED
 Enztec Trinket 3/8-16 UNC-02 4252-23582023-11-16
ENZTEC LIMITED
 Enztec Trinket M10x1.50-01 4252-23572023-11-16
ENZTEC LIMITED
 Enztec Trinket M10x0.75-01 4252-23562023-11-16
ENZTEC LIMITED
 Enztec Trinket 7/16-20 UNF-01 4252-23542023-11-16
ENZTEC LIMITED
 Enztec Trinket 3/8-24 UNF-02 4252-23532023-11-16
ENZTEC LIMITED
 Enztec Trinket 3/8-16 UNC-01 4252-23522023-11-16
ENZTEC LIMITED
 Enztec Trinket 3/8-24 UNF-01 4252-23612023-11-16
ENZTEC LIMITED
 Enztec Anvil 4252-23132023-11-16
ENZTEC LIMITED
 Enztec Handle 4252-23122023-11-16
ENZTEC LIMITED
 Enztec Classic OCI X – Corin 4252-23202023-11-16
ENZTEC LIMITED
 Hudson Large AO Adaptor 9000201122023-11-08
ENZTEC LIMITED
 Enztec Premium Patella Saw Guide – 10mm (1.37mm Blade) 4240-44102023-11-01
ENZTEC LIMITED
 Enztec Premium Patella Saw Guide – 9mm (1.37mm Blade) 4240-44092023-11-01
ENZTEC LIMITED
 Enztec Reamer - Bridgeback - Sz49 4250-71492023-10-12
ENZTEC LIMITED
 Adjustable Tibial Stylus – Slot 4240-72512023-10-05
ENZTEC LIMITED
 Enztec Femoral Impactor with Slap Hammer 4240-32002023-10-05
ENZTEC LIMITED
 Enztec 3.0mm Premium Pin Puller 4000-73002023-10-03
ENZTEC LIMITED
 Collo-MIS Double Offset Handle Right 9095.11.0092023-10-03
ENZTEC LIMITED
 Collo-MIS Double Offset Handle Left 9095.11.0102023-10-03
ENZTEC LIMITED
 Enztec Femoral Impactor with Slap Hammer - Narrow Head 4240-32062023-09-28
ENZTEC LIMITED
 Enztec Femoral Impactor Narrow Head 4240-32052023-09-28
ENZTEC LIMITED
 Enztec Femoral Impactor – S+N 4240-30922023-09-28
ENZTEC LIMITED
 Femoral Impactor Head – S+N 4240-30912023-09-28
ENZTEC LIMITED
 Glenoid Neck Retractor 4020-40022023-09-22
ENZTEC LIMITED
 Posterior Glenoid Neck Retractor 4020-40012023-09-22
ENZTEC LIMITED
 Enztec Classic OCI - Trinket M8x0.75-01 4252-20872023-09-19
ENZTEC LIMITED
 RI.KNEE Tracker Adapter 4240-75052023-08-02
ENZTEC LIMITED
 RI.KNEE Tibia Cut Guide Right 4240-75042023-08-02
ENZTEC LIMITED
 RI.KNEE Tibia Cut Guide Left 4240-75032023-08-02
ENZTEC LIMITED
 RI.KNEE Tibia Fixation Base Right 4240-75022023-08-02
ENZTEC LIMITED
 RI.KNEE Tibia Fixation Base Left 4240-75012023-08-02
ENZTEC LIMITED
 RI.KNEE Tibia Adjustment 4240-75002023-08-02
ENZTEC LIMITED
 Enztec Straight Broach Holder 1124.00.0002023-07-26
ENZTEC LIMITED
 Enztec Double Offset Broach Holder, Left 1122.00.0002023-07-26
ENZTEC LIMITED
 Enztec Double Offset Broach Holder, Right 1121.00.0002023-07-26

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