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.
| Registration Number | 3012495575 |
| FEI Number | 3012495575 |
| Name | SURGENTEC LLC |
| Owner & Operator | SurGenTec LLC |
| Contact Address | 911 Clint Moore Rd Boca Raton FL 33487 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 911 Clint Moore Rd Boca Raton, FL 33487 US |
| Establishment Type |
|
Device Company | Device | Date |
|---|---|---|
| SURGENTEC, LLC | OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 10cc | 2025-06-18 |
| SURGENTEC, LLC | OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 5cc | 2025-06-18 |
| SURGENTEC, LLC | OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 2.5cc | 2025-06-18 |
| SURGENTEC, LLC | OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 1cc | 2025-06-18 |
| SURGENTEC, LLC | OsteoFlo Synthetic Nanoputty Cartridge Graftgun Combo Kit - 10cc | 2025-06-18 |
| SURGENTEC, LLC | OsteoFlo Synthetic Nanoputty Cartridge Graftgun Combo Kit - 5cc | 2025-06-18 |
| SURGENTEC, LLC | Plat Tip Adapter – Small | 2025-06-18 |
| SURGENTEC, LLC | Plat Tip Adapter – Medium | 2025-06-18 |
| SURGENTEC, LLC | Plat Tip Adapter – Large | 2025-06-18 |
| SURGENTEC, LLC | Global Tip Adapter Package | 2025-06-18 |
| SURGENTEC, LLC | Bullet Tip Adapter Package | 2025-06-18 |
| SURGENTEC, LLC | Narrow Tip Adapter Package | 2025-06-18 |
| SURGENTEC, LLC | Graftgun Universal Kit – Additional 5cc Graftgun Tube | 2025-06-18 |
| SURGENTEC, LLC | Universal Graftgun Kit | 2025-06-18 |
| SURGENTEC, LLC | OsteoFlo HydroPutty Synthetic HFP - 12cc Labeled - IOSAL | 2025-06-18 |
| SURGENTEC, LLC | OsteoFlo HydroPutty Synthetic HFP - 6cc Labeled - IOSAL | 2025-06-18 |
| SURGENTEC, LLC | OsteoFlo Synthetic Nanoputty Cartridge - 10cc - IOSAL | 2025-06-18 |
| SURGENTEC, LLC | OsteoFlo Synthetic Nanoputty Cartridge - 10cc - IOSAL | 2025-06-18 |
| SURGENTEC, LLC | OsteoFlo Synthetic Nanoputty Syringe - 10cc - IOSAL | 2025-06-18 |
| SURGENTEC, LLC | OsteoFlo Synthetic Nanoputty Syringe - 5cc - IOSAL | 2025-06-18 |
| SURGENTEC, LLC | OsteoFlo Synthetic HydroPutty HFP - 12cc | 2025-06-18 |
| SURGENTEC, LLC | OsteoFlo Synthetic HydroPutty HFP - 6cc | 2025-06-18 |
| SURGENTEC, LLC | OsteoFlo Synthetic HydroPutty HFP - 3cc | 2025-06-18 |
| SURGENTEC, LLC | OsteoFlo Synthetic HydroPutty HFP - 1cc | 2025-06-18 |
| SURGENTEC, LLC | TiLink-P Screw 12mm x 30mm | 2025-06-18 |
| SURGENTEC, LLC | TiLink-L Implant 60mm x 10mm | 2025-06-18 |
| SURGENTEC, LLC | TiLink-L Implant 55mm x 10mm | 2025-06-18 |
| SURGENTEC, LLC | TiLink-L Implant 50mm x 10mm | 2025-06-18 |
| SURGENTEC, LLC | TiLink-L Implant 45mm x 10mm | 2025-06-18 |
| SURGENTEC, LLC | TiLink-L Implant 40mm x 10mm | 2025-06-18 |
| SURGENTEC, LLC | TiLink-L Implant 35mm x 10mm | 2025-06-18 |
| SURGENTEC, LLC | TiLink-L Implant 30mm x 10mm | 2025-06-18 |
| SURGENTEC, LLC | ALARA® 11 Gauge Access Needle with Sheath Two Pack- Diamond Tip | 2025-05-07 |
| SURGENTEC, LLC | ALARA® 11 Gauge Access Needle with Sheath Two Pack- Diamond & Bevel Tip | 2025-05-07 |
| SURGENTEC, LLC | ALARA® 11 Gauge Access Needle with Sheath Two Pack- Bevel Tip | 2025-05-07 |
| SURGENTEC, LLC | ALARA® 11 Gauge Access Needle with Sheath - Diamond Tip | 2025-05-07 |
| SURGENTEC, LLC | ALARA® 11 Gauge Access Needle with Sheath - Bevel Tip | 2025-05-07 |
| SURGENTEC, LLC | ALARA® 11 Gauge Access Needle Two Pack- Diamond Tip | 2025-05-07 |
| SURGENTEC, LLC | ALARA® 11 Gauge Access Needle Two Pack- Diamond & Bevel Tip | 2025-05-07 |
| SURGENTEC, LLC | ALARA® 11 Gauge Access Needle Two Pack- Bevel Tip | 2025-05-07 |
| SURGENTEC, LLC | ALARA® 11 Gauge Access Needle - Diamond Tip | 2025-05-07 |
| SURGENTEC, LLC | ALARA® 11 Gauge Access Needle - Bevel Tip | 2025-05-07 |
| SURGENTEC, LLC | ALARA 11 Gauge Access Needle with Sheath - Diamond Tip | 2025-05-07 |
| SURGENTEC, LLC | ALARA 11 Gauge Access Needle with Sheath - Bevel Tip | 2025-05-07 |
| SURGENTEC, LLC | TiLink-P Screw 12mm x 25mm | 2025-05-05 |
| SURGENTEC, LLC | TiLink-P Anchor | 2025-05-05 |
| SURGENTEC, LLC | Cage Adapter - Small | 2025-03-24 |
| SURGENTEC, LLC | Cage Adapter - Large | 2025-03-24 |
| SURGENTEC, LLC | Oval Tip Adapter - 4.5 X 7.5 | 2025-03-24 |
| SURGENTEC, LLC | PLAT Tip Adapter Large | 2025-03-24 |
| SURGENTEC, LLC | PLAT Tip Adapter Medium | 2025-03-24 |
| SURGENTEC, LLC | Narrow Rectangular Access Tip Adapter | 2025-03-24 |
| SURGENTEC, LLC | Rectangular Access Tip Adapter | 2025-03-24 |
| SURGENTEC, LLC | Global Tip Adapter | 2025-03-24 |
| SURGENTEC, LLC | Bullet Tip Adapter | 2025-03-24 |
| SURGENTEC, LLC | Bullet Global Tip Adapter | 2025-03-24 |
| SURGENTEC, LLC | Global Tip Adapter - Narrow | 2025-03-24 |
| SURGENTEC, LLC | Global Tip Adapter - Long | 2025-03-24 |
| SURGENTEC, LLC | 11" Stainless Steel Guidewire | 2025-03-17 |
| SURGENTEC, LLC | 9" Stainless Steel Guidewire | 2025-03-17 |
| SURGENTEC, LLC | 4.5mm Drill Bit | 2025-03-17 |
| SURGENTEC, LLC | Decortication Rasp - Curved | 2025-03-13 |
| SURGENTEC, LLC | Bone Graft Funnel | 2025-03-13 |
| SURGENTEC, LLC | Decortication Rasp - Straight | 2025-03-04 |
| SURGENTEC, LLC | Decortication Rasp- Straight | 2025-03-04 |
| SURGENTEC, LLC | Impact Rod | 2025-02-20 |
| SURGENTEC, LLC | Graftgun® Universal (GDS™) Graft Delivery System- Additional 5cc Graftgun Tube | 2025-02-20 |
| SURGENTEC, LLC | 7.5cc Graft Tube Steel | 2025-02-20 |
| SURGENTEC, LLC | 5cc Graft Tube Steel | 2025-02-20 |
| SURGENTEC, LLC | 7.5cc Graft Tube Pusher | 2025-02-20 |
| SURGENTEC, LLC | 5cc Graft Tube Pusher | 2025-02-20 |
| SURGENTEC, LLC | GraftGun Universal Graft Delivery System - Additional 5cc Graft Tube - IOSAL | 2025-02-20 |
| SURGENTEC, LLC | GraftGun Universal Kit - IOSAL | 2025-02-20 |
| 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 - 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 | Ion Facet Screw System | 2022-02-25 |
SurGenTec, LLC | OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft | 2020-08-14 |
SURGENTEC LLC | ALARA Neuro Access Kit | 2019-07-17 |
SurGenTec, LLC | ALARA Neuro Access Kit | 2019-07-16 |
SURGENTEC LLC | ALARA Access Needle | 2018-11-12 |
SURGENTEC LLC | Graftgun Universal Graft Delivery System | 2018-07-02 |
SURGENTEC LLC | Graftgun Universal Graft Delivery System - Cartridge Kit | 2018-07-02 |
SURGENTEC LLC | Delivery Cartridge Kit (Handle and Plunger Only) | 2018-07-02 |
Surgentec, LLC | Graftgun Universal Graft Delivery System | 2018-05-10 |
SURGENTEC LLC | Universal Delivery Kit Complete | 2017-07-31 |
SURGENTEC LLC | Graftgun Universal Graft Delivery System | 2017-07-31 |
Surgentec, LLC | Graftgun Universal Graft Delivery System | 2017-07-19 |
| NCAGE Code | 8LX99 | SURGENTEC, LLC |
| CAGE Code | 8LX99 | SURGENTEC, LLC SURGENTEC |
| DUNS | 004095409 | Surgentec, LLC |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 201803026224 | Yantian,China (Mainland) -> Charleston, South Carolina | PLASTIC BOX(PLASTIC TRAY FOR PACKAGING,PACKING BOX | 311 CTN |