Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015075784

FEI Number

3015075784

Entity Name

TIGON MEDICAL LLC

City/State/Country

Millersville, MD, US

Establishment Address

303 Najoles Road, Suite 104, Millersville, MD 21108, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Tigon Medical LLC (Owner Number: 10059738)

Owner / Operator Contact Address

303 Najoles Road, Suite 104, Millersville, MD 21108, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K240175

PMA Number

N/A

All Registered Proprietary Names

Manticore Tigon Tomahawk, Dual Infinity, Eye-Deal, and Tenodesis Anchors Boomerang Button Tigon Medical Javelin All-Suture Anchors Tigon Medical Fractures, Instability, and Reconstruction (FIRE)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2019-02-18
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-04-19
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2021-08-27
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-01-07
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-01-07
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-01-07

Official Correspondent

Jeremy Clark

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Tigon Medical 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
K193295	Parcus Medical, LLC	Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor	2020-01-23
K193606	Conmed Corporation	Y-Knot OneStep Anchor	2020-01-22
K984200	R. Thomas Grotz, M.D., Inc.	STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE	1999-01-21
K171060	Riverpoint Medical	OrthoButton AL	2017-06-02
K231867	Paragon 28, Inc.	Grappler Suture Anchor System	2023-08-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015075784. Last updated year: 2026. Please use registration number 3015075784 when referencing this establishment in official correspondence.