Data / Medical devices / United States / Orthopedic Designs North America, Inc.
Orthopedic Designs North America, Inc.: FDA-registered device maker in Tampa, FL, United States, 9 510(k) clearances
Orthopedic Designs North America, Inc. is registered with the FDA (registration 1064129) in Tampa, FL, United States. It lists 15 device types. The FDA files 9 510(k) clearances under its listings, the newest dated November 5, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1064129
- FEI number
- 3002684506
- Address
- 5912 Breckenridge Parkway Suite F, Tampa, FL, United States, 33610
- Owner or operator
- Orthopedic Designs North America, Inc. (10031399)
- Roles
- Manufacturer
- First device listed
- January 25, 2010
- Registered through
- 2026
- Brand names listed
- 6.1mm Reamer, 7.5mm Tap, Atlas Humeral Nail System, Awl, Ball Tip Sheathed Guide Wire (600mm & 900mm), CCD Instrument Tray, Cannulated Compression Device System, Compression Nut Driver and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Awl | HWJ | 1 | Manufacturer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Manufacturer | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Manufacturer | accessdata.fda.gov |
| Impactor | HWA | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Compression | HWN | 1 | Manufacturer | accessdata.fda.gov |
| Nail, Fixation, Bone | JDS | 2 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | accessdata.fda.gov |
| Reamer | HTO | 1 | Manufacturer | accessdata.fda.gov |
| Rod, Fixation, Intramedullary And Accessories | HSB | 2 | Manufacturer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Manufacturer | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Manufacturer | accessdata.fda.gov |
| Template | HWT | 1 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Manufacturer | accessdata.fda.gov |
| Washer, Bolt Nut | HTN | 2 | Manufacturer | accessdata.fda.gov |
| Wrench | HXC | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 5, 2024 | K241484 | Atlas Humeral Nail System | HSB | Substantially Equivalent | Orthopedic Designs North America, Inc. (Odi-Na) | accessdata.fda.gov |
| April 13, 2022 | K210146 | Cannulated Compression Device System | HWC | Substantially Equivalent | Orthopedic Designs North America, Inc. | accessdata.fda.gov |
| February 22, 2018 | K173255 | Talon DistalFix Humeral Nail | HSB | Substantially Equivalent | Orthopedic Designs North America, Inc. | accessdata.fda.gov |
| November 3, 2015 | K152295 | Talon DistalFix Antegrade/Retrograde Femoral Nail | HSB | Substantially Equivalent | Orthopedic Designs North America, Inc. | accessdata.fda.gov |
| August 22, 2011 | K111352 | TALON DISTALFIX PROXIMAL FEMORAL NAIL | HSB | Substantially Equivalent | Orthopedic Designs North America, Inc. | accessdata.fda.gov |
| January 12, 2004 | K033286 | ODI TALON LONG PROXIMAL FEMORAL NAIL SYSTEM | HSB | Substantially Equivalent | Orthopedic Designs, Inc. (Odi) | accessdata.fda.gov |
| April 1, 2003 | K030619 | ODI 7.0MM CANNULATED SCREW SYSTEM | HTN | Substantially Equivalent | Orthopedic Designs, Inc. | accessdata.fda.gov |
| March 21, 2002 | K014189 | ODI TALON INTRAMEDULLARY HIP NAIL | JDS | Substantially Equivalent | Orthopedic Designs, Inc. | accessdata.fda.gov |
| January 20, 1999 | K984331 | ODI ULTIMATE COMPRESSION HIP SCREW | HWC | Substantially Equivalent | Orthopedic Designs, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Tray, Surgical, Instrument
- All makers of Awl
- All makers of Gauge, Depth
- All makers of Rod, Fixation, Intramedullary And Accessories
- All makers of Bit, Drill
- All makers of Nail, Fixation, Bone
Updated November 5, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.