Surgentec L L C

FDA Filings

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

FDA Registration(s)
Registration Number3012495575
FEI Number3012495575
NameSURGENTEC LLC
Owner & OperatorSurGenTec LLC
Contact Address911 Clint Moore Rd
Boca Raton FL 33487 US
Official Correspondent
  • Travis Greenhalgh
  • 001-561-9907882-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address911 Clint Moore Rd
Boca Raton, FL 33487 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
SURGENTEC, LLC
Decortication Rasp - Fixed Curved 2025-02-04
SURGENTEC, LLC
Site Prep Barbed Guide +4 2025-01-13
SURGENTEC, LLC
Site Prep Barbed Guide +2 2025-01-13
SURGENTEC, LLC
Site Prep Barbed Guide 2025-01-13
SURGENTEC, LLC
Site Prep Locator - Row Series 2025-01-13
SURGENTEC, LLC
Bone Marrow Access Needle with Sheath - 25x Max 2025-01-13
SURGENTEC, LLC
BMAC Bevel Needle Kit - Two Pack 2025-01-13
SURGENTEC, LLC
BMAC Bevel Needle - Two Pack 2025-01-13
SURGENTEC, LLC
BMAC Bevel Needle Kit 2025-01-13
SURGENTEC, LLC
BMAC Bevel Needle 2025-01-13
SURGENTEC, LLC
BMAC Bevel Needle Pouched 2025-01-13
SURGENTEC, LLC
BMAC Bevel Needle Assembly 2025-01-13
SURGENTEC, LLC
Spinous Process Plate, 16mm 2025-01-13
SURGENTEC, LLC
Spinous Process Plate, 14mm 2025-01-13
SURGENTEC, LLC
Spinous Process Plate, 12mm 2025-01-13
SURGENTEC, LLC
Spinous Process Plate, 10mm 2025-01-13
SURGENTEC, LLC
Spinous Process Plate, 8mm 2025-01-13
SURGENTEC, LLC
BMAC Diamond Needle Kit - Two Pack Copy 2025-01-08
SURGENTEC, LLC
BMAC Diamond Needle - Two Pack 2025-01-08
SURGENTEC, LLC
BMAC Diamond Needle Kit 2025-01-08
SURGENTEC, LLC
BMAC Diamond Needle 2025-01-08
SURGENTEC, LLC
BMAC Diamond Needle Pouched 2025-01-08
SURGENTEC, LLC
BMAC Diamond Needle Assembly 2025-01-08
SURGENTEC, LLC
BMAN Solid Diamond Needle Kit - Two Pack 2025-01-08
SURGENTEC, LLC
BMAN Solid Diamond Needle - Two Pack 2025-01-08
SURGENTEC, LLC
BMAN Solid Diamond Needle Kit 2025-01-08
SURGENTEC, LLC
BMAN Solid Diamond Needle 2025-01-08
SURGENTEC, LLC
BMAN Solid Diamond Needle Pouched 2025-01-08
SURGENTEC, LLC
BMAN Solid Diamond Needle Assembly 2025-01-03
SURGENTEC, LLC
3/4 inch Cobb 2024-12-26
SURGENTEC, LLC
GraftRasp Sterilization Tray 2024-12-26
SURGENTEC, LLC
13mm Dilator 2024-12-26
SURGENTEC, LLC
20mm Dilator 2024-12-26
SURGENTEC, LLC
17mm Dilator 2024-12-26
SURGENTEC, LLC
10mm Dilator 2024-12-26
SURGENTEC, LLC
6mm Dilator 2024-12-26
SURGENTEC, LLC
Guide Pin - Bevel 2024-12-17
SURGENTEC, LLC
Lateral Removal Tool 2024-11-11
SURGENTEC, LLC
Lateral Graft Tamp 2024-11-11
SURGENTEC, LLC
Lateral SI Screw Drill Bit - 8mm 2024-11-11
SURGENTEC, LLC
Lateral SI Screw Inserter Torque Driver 2024-11-11
SURGENTEC, LLC
Lateral Impact Cap 2024-11-11
SURGENTEC, LLC
TILINK-L GUIDE PIN LOCATOR 2024-11-11
SURGENTEC, LLC
Lateral Drill Guide 2024-11-11
SURGENTEC, LLC
Lateral Dilator 2024-11-11
SURGENTEC, LLC
Guidewire - 12" 2024-11-11
SURGENTEC, LLC
TiLink-L Reamer - 3/16" Square Connection 2024-11-11
SURGENTEC, LLC
TiLink-L Screw Drill Bit - 8mm - 3/16" Square Connection 2024-11-11
SURGENTEC, LLC
TiLink-L Screw Inserter Hexalobe Driver - 3/16" Square Connection 2024-11-11
SURGENTEC, LLC
TiLink-L Screw Drill Bit - 8mm 3D Printed 2024-11-11
SURGENTEC, LLC
TILINK-L GUIDE PIN LOCATOR 16mm 2024-11-11
SURGENTEC, LLC
Guidewire - 15.5" 2024-11-11
SURGENTEC, LLC
TiLink-L Bone Graft Pusher Assembly 2024-11-11
SURGENTEC, LLC
TiLink-L Bone Graft Funnel 2024-11-11
SURGENTEC, LLC
TiLink-L Reamer 2024-11-11
SURGENTEC, LLC
TiLink-L Sterilization Tray 2024-11-11
SURGENTEC, LLC
TiLink-L Implant Caddy 2024-11-11
SURGENTEC, LLC
TiLink-L Transfer Pin 2024-11-11
SURGENTEC, LLC
SI-Lateral Ratcheting T-Handle 2024-11-11
SURGENTEC, LLC
TILINK-P INSERTER THREADED ROD ASSEMBLY - 25MM 2024-11-08
SURGENTEC, LLC
TiLink-P Disposable Inserter Main Body 2024-11-08
SURGENTEC, LLC
Disposable Pin Puller 2024-11-08
SURGENTEC, LLC
TiLink-P Disposable Instrument Removal Tool 2024-11-08
SURGENTEC, LLC
TiLink-P Disposable Graft Tamp 2024-11-08
SURGENTEC, LLC
TiLink-P Disposable Impact Cap 2024-11-08
SURGENTEC, LLC
TiLink-P Disposable Inserter Hexalobe Driver 2024-11-08
SURGENTEC, LLC
TiLink-P Disposable Inserter Threaded Rod - 30mm 2024-11-08
SURGENTEC, LLC
TiLink-P Disposable Inserter Threaded Rod Assembly 2024-11-08
SURGENTEC, LLC
TiLink-P Disposable Drill Bit 2024-11-08
SURGENTEC, LLC
TiLink-P Disposable Drill Guide Dilator 2024-11-08
SURGENTEC, LLC
TiLink-P Disposable Joint Rasp 2024-11-08
SURGENTEC, LLC
Disposable 5.5mm Drill Bit 2024-10-01
SURGENTEC, LLC
Disposable 5.0mm Drill Bit 2024-10-01
SURGENTEC, LLC
Disposable 4.5mm Drill Bit 2024-10-01
SURGENTEC, LLC
Disposable Instrument Removal Tool 2024-10-01
SURGENTEC, LLC
Disposable Impactor - No Guidewire 2024-10-01
SURGENTEC, LLC
Disposable Graft Tamp 2024-10-01
SURGENTEC, LLC
Disposable Impactor 2024-10-01
SURGENTEC, LLC
Disposable Circular Decortication Rasp 2024-10-01
SURGENTEC, LLC
ION Disposable XXXX 2024-10-01
SURGENTEC, LLC
ION Disposable XXXX 2024-10-01
SURGENTEC, LLC
ION Disposable XXXX 2024-10-01
SURGENTEC, LLC
ION Disposable Plastic Drill Guide 2024-09-30
SURGENTEC, LLC
ION Disposable Facet Screw Inserter AO 2024-09-30
SURGENTEC, LLC
Site Prep Impactor 2024-09-20
SURGENTEC, LLC
Site Prep Removal Tool 2024-09-20
SURGENTEC, LLC
Site Prep Locator - Flat Series 2024-09-20
SURGENTEC, LLC
Site Prep Locator - Teeth Series 2024-09-20
SURGENTEC, LLC
Site Prep Rasp 2024-09-20
SURGENTEC, LLC
Removal Sleeve 2024-09-20
SURGENTEC, LLC
Facet Screw Inserter AO - Cannulated Removal 2024-09-20
SURGENTEC, LLC
Decortication Rasp 2024-09-20
SURGENTEC, LLC
Facet Locator - Long 2024-09-20
SURGENTEC, LLC
Graft Tamp 2024-09-20
SURGENTEC, LLC
Impactor 7mm 2024-09-20
SURGENTEC, LLC
Plastic Circular Decortication Rasp 2024-09-20
SURGENTEC, LLC
Plastic Drill Guide Non-Cervical 2024-09-20
SURGENTEC, LLC
5.5mm Drill Bit - Non-Cervical 2024-09-20
SURGENTEC, LLC
5.0mm Drill Bit - Non-Cervical 2024-09-20
SURGENTEC, LLC
4.5mm Drill Bit - Non-Cervical 2024-09-20
SurGenTec, LLC
Ion Facet Screw System2022-02-25
SurGenTec, LLC
OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft2020-08-14
SURGENTEC LLC
ALARA Neuro Access Kit2019-07-17
SurGenTec, LLC
ALARA Neuro Access Kit2019-07-16
SURGENTEC LLC
ALARA Access Needle2018-11-12
SURGENTEC LLC
Graftgun Universal Graft Delivery System2018-07-02
SURGENTEC LLC
Graftgun Universal Graft Delivery System - Cartridge Kit2018-07-02
SURGENTEC LLC
Delivery Cartridge Kit (Handle and Plunger Only)2018-07-02
Surgentec, LLC
Graftgun Universal Graft Delivery System2018-05-10
SURGENTEC LLC
Universal Delivery Kit Complete2017-07-31
SURGENTEC LLC
Graftgun Universal Graft Delivery System2017-07-31
Surgentec, LLC
Graftgun Universal Graft Delivery System2017-07-19

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
201803026224Yantian,China (Mainland) -> Charleston, South CarolinaPLASTIC BOX(PLASTIC TRAY FOR PACKAGING,PACKING BOX311 CTN

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