Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016261131

FEI Number

3016261131

Entity Name

GUARDIAN MEDICAL USA, INC

City/State/Country

Swanton, OH, US

Establishment Address

11360 S Airfield Rd, Swanton, OH 43558, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Guardian Medical USA, LLC (Owner Number: 10062293)

Owner / Operator Contact Address

11360 S Airfield Rd, Swanton, OH 43558, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CoLink Plating System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2026-05-29
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-12-30
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-12-30
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2020-01-09
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2020-01-09
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2020-01-09
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-06-27
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-06-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-06-27
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-06-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-06-27
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-06-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-06-27
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-10-04
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-10-04
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2024-10-04
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2024-06-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-06-27
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-06-27
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-06-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-06-27
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2026-06-02
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2026-06-02
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2024-10-04
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-10-04
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-10-04
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-06-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-06-27

Official Correspondent

Tracy Momany

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Guardian Medical USA, 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
K213667	SI-BONE, Inc.	iFuse-TORQ® Implant System	2022-06-10
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08
K063244	Arc Surgical, LLC	ARC SURGICAL BONE REDUCTION SCREW	2006-12-27
K972722	Orthopedic Designs, Inc.	ULTIMATE COMPRESSION SCREW SYSTEM	1998-01-23
K192974	Tyber Medical, LLC	Tyber Medical Trauma Screw	2020-01-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0043-2018	MicroPort Orthopedics Inc.	2	MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016261131. Last updated year: 2026. Please use registration number 3016261131 when referencing this establishment in official correspondence.