Data / Medical devices / United States / NUTEK Orthopaedics, Inc
NUTEK Orthopaedics, Inc: FDA-registered device maker in Fort Lauderdale, FL, United States, 4 510(k) clearances
NUTEK Orthopaedics, Inc is registered with the FDA (registration 3005893246) in Fort Lauderdale, FL, United States. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 15, 2013. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3005893246
- Address
- 641 SW 3rd Ave, Fort Lauderdale, FL, United States, 33315
- Owner or operator
- NUTEK ORTHOPAEDICS, INC. (9091870)
- Roles
- Specification developer
- First device listed
- September 5, 2006
- Registered through
- 2026
- Brand names listed
- First Assistant Reduction Device, Fist Assistant, NBX Shoulder, NBX Wrist
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | 2 | Specification developer | accessdata.fda.gov |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | LXT | 2 | Specification developer | accessdata.fda.gov |
| Component, Traction, Invasive | JEC | 2 | Specification developer | accessdata.fda.gov |
| Component, Traction, Non-Invasive | KQZ | 1 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| May 15, 2013 | K122777 | NBX - NON BRIDGING EXTERNAL FIXATOR HAND | KTT | Substantially Equivalent | Nutek Orthopaedics, Inc. | accessdata.fda.gov |
| February 5, 2009 | K082833 | NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER | KTT | Substantially Equivalent | Nutek Orthopaedics, Inc. | accessdata.fda.gov |
| April 15, 2002 | K020905 | NBX - NON-BRIDGING EXTERNAL FIXATOR | LXT | Substantially Equivalent | Biomet Orthopedics, Inc. | accessdata.fda.gov |
| December 29, 2000 | K003240 | BIOMET EXTERNAL WRIST PLATE | LXT | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- All makers of Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
- All makers of Component, Traction, Non-Invasive
- All makers of Component, Traction, Invasive
Updated May 15, 2013. 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.