MOUNT MFG

FDA Device Registration & Listing · Marquette, MI, US · Registration 3016084569

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3016084569
FEI Number
3016084569
Entity Name
MOUNT MFG
City/State/Country
Marquette, MI, US
Establishment Address
875 Brookton Rd, Marquette, MI 49855, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Mount Mfg (Owner Number: 10062036)
Owner / Operator Contact Address
875 Brookton Rd, Marquette, MI 49855, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Gorilla Ankle Fracture Plating System Screws Monster Screw System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LXI Guide, Drill, Ligament General, Plastic Surgery Class 1 878.4820 2020-11-05
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2025-11-25
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2026-05-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-06-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-06-23
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2025-06-23
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2026-05-13
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2025-06-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-06-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-06-23
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2025-06-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-06-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-06-23
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-11-25
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2025-06-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-05-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-06-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-06-23
HXW Bender Orthopedic Class 1 888.4540 2025-06-23
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-11-25
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-06-23
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2025-06-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-11-24
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-05-13
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-05-13
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-11-25
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-11-25
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-11-25
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-11-25
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2026-05-13
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-11-25
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2025-11-25
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-11-25
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-05-13
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-11-25
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-11-25
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2026-05-13
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2026-05-13
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2023-03-07
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2026-05-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-06-22
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2026-05-13
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2026-05-13
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2025-06-23
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2025-06-23

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Mount Mfg
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
K033476 Howmedica Osteonics Corp. MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM 2004-01-20
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 3016084569. Last updated year: 2026. Please use registration number 3016084569 when referencing this establishment in official correspondence.
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