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Sign in to claim this brandOrthopedic Designs North America, Inc.
US
Last updated September 17, 2026
What Orthopedic Designs North America, Inc. makes
The company manufactures orthopedic fixation devices, including non-sliding bone screws (both non-bioabsorbable and non-sterile), intramedullary nails for the femur and humerus, bone nail end-caps, single-use guidewires, rigid medullary canal reamers, and reusable surgical screwdrivers. Examples include cortical locking screws, distal fixation end caps, intramedullary hip nails, and cannulated screw systems designed for internal fracture stabilization.
These devices are classified under FDA’s Class I and Class II regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Orthopedic Designs North America, Inc. manufacture?
Orthopedic Designs North America, Inc. specializes in orthopedic fixation devices. Their products include non-sliding bone screws (both non-bioabsorbable and non-sterile), intramedullary nails for the femur and humerus, bone nail end-caps, single-use guidewires, rigid medullary canal reamers, and reusable surgical screwdrivers. These devices are designed for internal fracture stabilization and bone alignment, such as cortical locking screws, distal fixation end caps, and intramedullary hip nails.
Where is Orthopedic Designs North America, Inc. based?
The company is based in the United States. This location is relevant for regulatory compliance and distribution, as it aligns with FDA oversight for devices marketed in the US.
Which regulatory registries list Orthopedic Designs North America, Inc.’s devices?
The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for authorized devices, allowing healthcare providers and regulators to verify product details, such as manufacturer information and classification.
How are Orthopedic Designs North America, Inc.’s devices classified under FDA regulations?
The company’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. Classification depends on factors like the device’s intended use and potential harm if misused.
Why are some of Orthopedic Designs North America, Inc.’s devices classified as Class II?
Class II classification applies to devices that are not low-risk but also do not require the stringent premarket approval process of Class III. For example, intramedullary nails and certain bone screws are classified as Class II because they involve internal fixation, where improper use or failure could lead to complications like improper bone alignment or hardware-related injuries. Special controls, such as performance standards or post-market surveillance, help mitigate these risks.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 5912 Breckenridge Parkway, Tampa, FL, 33610
- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
- 3002684506
- DUNS Number
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Catalogue (380)
Page 6 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Talon™ DistalFix™ ART Cortical Screw | ART5075NS | FDA UDI | Class II | Active |
| Talon™ DistalFix™ Humeral Nail | HTN409315 | FDA UDI | Class II | Active |
| Trocar Tip Wire | SLNT33 | FDA UDI | Class I | Active |
| Handle-Arm Screw | ODIU11 | FDA UDI | Class I | Active |
| Cannulated Compression Device (CCD) System | CCD7516085NS | FDA UDI | Class II | Active |
| Talon™ DistalFix™ Proximal Femoral Nail | SLN12532R | FDA UDI | Class II | Active |
| Atlas™ Humeral Nail System | AHN5040NS | FDA UDI | Class II | Active |
| Driver Shaft | ODIT141 | FDA UDI | Class I | Active |
| Guide Arm Lock | SLNT0305 | FDA UDI | Class I | Active |
| Talon™ DistalFix™ A/R Femoral Nail | ART12420 | FDA UDI | Class II | Active |
| Talon™ DistalFix™ Humeral Nail | HTN409285 | FDA UDI | Class II | Active |
| Cannulated Compression Device (CCD) System | CCD7516055NS | FDA UDI | Class II | Active |
| Atlas™ Humeral Nail System | AS5042 | FDA UDI | Class II | Active |
| Dual Core Cortical Locking Screw | HTNU424 | FDA UDI | Class II | Active |
| Atlas™ Humeral Nail System | AHN5038NS | FDA UDI | Class II | Active |
| Talon™ DistalFix™ ART Cortical Screw | ART5030NS | FDA UDI | Class II | Active |
| Atlas™ Humeral Nail System | AHN11C10L | FDA UDI | Class II | Active |
| Talon™ Compression Hip Screw System | THS150254 | FDA UDI | Class II | Active |
| Talon™ DistalFix™ ART Cortical Screw | ART5065 | FDA UDI | Class II | Active |
| Talon™ DistalFix™ Lag Screw | SLN011075 | FDA UDI | Class II | Active |
| Screw Depth Gauge | ODIT126 | FDA UDI | Class I | Active |
| Round Tip Wire | SLNT34 | FDA UDI | Class I | Active |
| Torque Limiting Handle | ODIU07 | FDA UDI | Class I | Active |
| Talon™ DistalFix™ HTN End Cap | HTN10C05 | FDA UDI | Class II | Active |
| Talon™ DistalFix™ Proximal Femoral Nail | SLN12540R | FDA UDI | Class II | Active |
| Talon™ DistalFix™ Humeral Nail | HTN410180 | FDA UDI | Class II | Active |
| Talon™ Compression Hip Screw System | THS045056 | FDA UDI | Class II | Active |
| Atlas™ Humeral Nail System | AHN5052NS | FDA UDI | Class II | Active |
| Lag Guide Pin Placement Aid | SLNT0306 | FDA UDI | Class I | Active |
| Talon DistalFix A/R Femoral Nail Instrument Tray | ODIF100 | FDA UDI | Class I | Active |
| Talon™ DistalFix™ ART Cortical Screw | ART5100NS | FDA UDI | Class II | Active |
| Ratcheting Axial Handle | SLNT04 | FDA UDI | Class I | Active |
| Atlas™ Humeral Nail System | AS5048 | FDA UDI | Class II | Active |
| Talon™ Compression Hip Screw System | THS127085 | FDA UDI | Class II | Active |
| Atlas™ Humeral Nail System | AS5056 | FDA UDI | Class II | Active |
| Atlas™ Humeral Nail System | AS5040 | FDA UDI | Class II | Active |
| Atlas™ Humeral Nail System | AHN11C00L | FDA UDI | Class II | Active |
| Talon™ DistalFix™ Humeral Nail | HTN408315 | FDA UDI | Class II | Active |
| Talon™ DistalFix™ HTN End Cap Locking | HTN10C05L | FDA UDI | Class II | Active |
| Talon™ DistalFix™ ART Cortical Screw | ART5115 | FDA UDI | Class II | Active |
| Trocar | ODIF15 | FDA UDI | Class I | Active |
| Nail-Handle Connector Screw | ODIF09 | FDA UDI | Class I | Active |
| Talon™ DistalFix™ Lag Screw | SLN011080 | FDA UDI | Class II | Active |
| Talon™ DistalFix™ Humeral Nail | HTN409240 | FDA UDI | Class II | Active |
| Lag Driver | SLNT30 | FDA UDI | Class I | Active |
| Talon™ Compression Hip Screw System | THS127090 | FDA UDI | Class II | Active |
| Talon™ Compression Hip Screw System | THS045054 | FDA UDI | Class II | Active |
| Impactor | ODIU03 | FDA UDI | Class I | Active |
| Knob Wrench | SLNT11 | FDA UDI | Class I | Active |
| Atlas™ Humeral Nail System | AHN08225L | FDA UDI | Class II | Active |
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