FDA Registration
Active
🇺🇸 United States
SURGENTEC LLC
Reg #: 3012495575
·
FEI: 3012495575
·
Expires 2026
Products
11
Proprietary Names
43
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- SURGENTEC LLC
- Registration Number
- 3012495575
- FEI Number
- 3012495575
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 911 Clint Moore Rd
- City
- Boca Raton
- State
- FL
- ZIP
- 33487
- Country
- US
Regulatory Submissions
- 510(k) Number
- K251720
Owner / Operator
- Firm Name
- SurGenTec LLC
- Operator Number
- 10055452
- Address
- 911 Clint Moore Rd
- City
- Boca Raton
- State
- FL
- Postal Code
- 33487
- Country
- US
- Correspondent
- Travis Greenhalgh
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2025-07-15 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2024-08-22 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2025-02-10 |
| Neurosurgical Nerve Locator | PDQ | Class 2 | Ear, Nose, Throat | No | 2019-07-17 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2024-01-02 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2020-11-06 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2024-07-09 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2020-08-04 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2024-08-12 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2018-11-12 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2026-05-13 |
Proprietary Names
Synthetic Fiber Kit
OsteoFlo Fiber Graft
TiLink-P SI Joint Fusion System
GraftGun Universal Graft Delivery System (GDS)
TiLink inSIte
Graftgun Universal Graft Delivery System
Graftgun Universal Graft Delivery System - Cartridge Kit
Delivery Cartridge Kit (Handle and Plunger Only)
ALARA Neuro Access Kit
OSTEOPOINT Neuro Access Needle
TiLink-L SI Joint Fusion System
Bacfuse 8 & 10mm
3D GraftRasp System
Ion 3D Facet Screw System
FacetCore Fusion System
Synthetic Fiber Graft
OsteoFlo HydroFiber
TiLink InSite
ION 55
ION 3D Cervical Disposable Kit
ION-C
ION 3D Non-Cervical Disposable Kit
ION-C Disposable Kit
Universal Delivery Kit Complete
ALARA BMA Neuro Access Kit
BONE MARROW ASPIRATE KIT
ALARA BMAN ACCESS
BONE MARROW ASPIRATE ACCESS KIT
ALARA BMAN
OsteoFlo
Bacfuse Line Extension
Facet Screw Spinal Device, Piston Syringe and Bone Rasp
ALARA Access Needle
OSTEOPOINT 11 Gauge Access Needle
ALARA BMAN BIOCORE
ALARA BMA Neuro Access
TiLink- L Navigation
TiLink-L SI Joint Fusion System - Special
ION 3D
ION 65
ION 60
ION 70
Ion Facet Screw System
Establishment Types
Manufacture Medical Device