Summit Orthopedic Technologies Inc.

FDA Device Registration & Listing · Naples, FL, US · Registration 3012491394

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
3012491394
FEI Number
3012491394
Entity Name
Summit Orthopedic Technologies Inc.
City/State/Country
Naples, FL, US
Establishment Address
2975 Horseshoe Drive South, Suite 100, Naples, FL 34104, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Summit Orthopedic Technologies Inc. (Owner Number: 10051828)
Owner / Operator Contact Address
2975 Horseshoe Drive South, Suite 100, Naples, FL 34104, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Paragon 28 Paragon 28 Corin

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-03-25
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-03-25
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2020-03-25
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2020-03-25
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2020-03-25
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2020-03-25
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2020-03-25
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2020-03-25
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2018-03-23
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-03-23

Official Correspondent

Jason Blake

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Summit Orthopedic Technologies Inc.
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
K042598 Zimmer, Inc. PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES 2004-10-29
K190842 Jiangsu Trauhui Medical Instrument Co., Ltd. Comus Locking Plate systems 2020-02-03
K130510 Arthrex, Inc. ARTHREX COMPRESSION PLATES 2013-09-25
K202803 Newclip Technics Activmotion S DTO 2021-12-16
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08

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 3012491394. Last updated year: 2026. Please use registration number 3012491394 when referencing this establishment in official correspondence.
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