Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012495575

FEI Number

3012495575

Entity Name

SURGENTEC LLC

City/State/Country

Boca Raton, FL, US

Establishment Address

911 Clint Moore Rd, Boca Raton, FL 33487, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SurGenTec LLC (Owner Number: 10055452)

Owner / Operator Contact Address

911 Clint Moore Rd, Boca Raton, FL 33487, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K253604

PMA Number

N/A

All Registered 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 TiLink-P SI Joint Fusion System 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 Graftgun Universal Graft Delivery System Universal Delivery Kit Complete GraftGun Universal Graft Delivery System (GDS) 3D GraftRasp System 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 ALARA BMAN ACCESS ALARA BMAN BIOCORE ALARA BMA Neuro Access TiLink- L Navigation

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2025-07-15
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2024-08-22
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2025-02-10
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2025-06-17
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2018-07-02
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2019-07-17
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2023-11-01
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2024-01-02
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2024-07-09
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2020-11-06
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2020-11-06
MRW	System, Facet Screw Spinal Device	Unknown	Class U	N/A	2024-07-09
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2024-07-09
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2024-07-09
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2020-08-04
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2025-01-08
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2026-03-30
MRW	System, Facet Screw Spinal Device	Unknown	Class U	N/A	2026-01-26
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2017-07-31
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2020-08-04
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2023-10-16
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2024-08-12
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2024-08-12
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2020-11-05
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2024-01-02
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2024-02-22
MRW	System, Facet Screw Spinal Device	Unknown	Class U	N/A	2024-02-22
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2024-02-22
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2018-11-12
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2025-04-25
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-05-13

Official Correspondent

Travis Greenhalgh

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SurGenTec LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K180121	Cellumed Co., Ltd.	Rafugen DBM	2018-04-11
K062691	Takiron Co., Ltd.	COMPORUS	2008-04-15
K023703	Berkeley Advanced Biomaterials, Inc.	BI-OSTETIC	2003-01-30
K173933	Xenco Medical, LLC	Sorrento Bioglass Bone Graft Substitute	2018-09-13
K213667	SI-BONE, Inc.	iFuse-TORQ® Implant System	2022-06-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012495575. Last updated year: 2026. Please use registration number 3012495575 when referencing this establishment in official correspondence.