Orthopedic Designs North America, Inc.

FDA Device Registration & Listing · Tampa, FL, US · Registration 1064129

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
1064129
FEI Number
3002684506
Entity Name
Orthopedic Designs North America, Inc.
City/State/Country
Tampa, FL, US
Establishment Address
5912 Breckenridge Parkway, Suite F, Tampa, FL 33610, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Orthopedic Designs North America, Inc. (Owner Number: 10031399)
Owner / Operator Contact Address
5912 Breckenridge Parkway, Suite F, Tampa, FL 33610, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Compression Sleeve Compressor Depth Gauge Screw Depth Gauge Lag Guide Pin Depth Gauge Cannulated Compression Device System Awl Curved Entry Awl ODI Talon Intramedullary Hip Nail Radiographic Talon Template Folding Nail Guide Wire Ruler Radiographic Ruler Guide Arm Guide Wire Ruler ODI Talon Long Prox Fem Nail Sys Proximal Reamer Modular Reamer Cutter Head Modular Flexible Reamer Shaft Entry Reamer 6.1mm Reamer 7.5mm Tap Impactor Extractor Impactor / Extractor ODI Ultimate Compression Hip Screw ODI 7mm Cannulated Screw System Cortical Drill

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HWN Instrument, Compression Orthopedic Class 1 888.4540 2022-08-12
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2022-08-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-06-16
HWJ Awl Orthopedic Class 1 888.4540 2022-08-12
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2010-01-25
HWT Template Orthopedic Class 1 888.4800 2013-12-20
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2010-01-25
HTO Reamer Orthopedic Class 1 888.4540 2015-12-29
HWX Tap, Bone Orthopedic Class 1 888.4540 2022-08-12
HWA Impactor Orthopedic Class 1 888.4540 2015-12-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2010-01-25
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2010-01-25
HTW Bit, Drill Orthopedic Class 1 888.4540 2022-08-12

Official Correspondent

Robin Wilson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Orthopedic Designs North America, 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
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
K082949 OrthoPediatrics Corp. ORTHOPEDIATRICS BONE SCREWS 2008-11-25

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 1064129. Last updated year: 2026. Please use registration number 1064129 when referencing this establishment in official correspondence.
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