Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005893246

FEI Number

3005893246

Entity Name

NUTEK Orthopaedics, Inc

City/State/Country

Fort Lauderdale, FL, US

Establishment Address

641 SW 3rd Ave, Fort Lauderdale, FL 33315, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

NUTEK ORTHOPAEDICS, INC. (Owner Number: 9091870)

Owner / Operator Contact Address

641 SW 3rd Ave, --, Fort Lauderdale, FL 33315, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K003240

PMA Number

N/A

All Registered Proprietary Names

Fist Assistant NBX Wrist

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JEC	Component, Traction, Invasive	Orthopedic	Class 2	888.3040	2024-12-23
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2024-12-23
LXT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite	Orthopedic	Class 2	888.3030	2006-09-05
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2006-09-05
LXT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite	Orthopedic	Class 2	888.3030	2006-09-05

Official Correspondent

PETER MINCIELI

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NUTEK ORTHOPAEDICS, 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
K033476	Howmedica Osteonics Corp.	MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM	2004-01-20
K020905	Biomet Orthopedics, Inc.	NBX - NON-BRIDGING EXTERNAL FIXATOR	2002-04-15
K063832	Synthes (Usa)	SYNTHES (USA) ELBOW HINGE FIXATOR	2007-03-07
K030390	Synthes (Usa)	SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP - MR SAFE	2003-04-01

Similar Registrations

Registration Number	Establishment Name	Location
3010860227	VIRAK ORTHOPEDICS LLC	Madison, NJ, US
9680825	ORTHOFIX SRL	BUSSOLENGO Verona, IT
3038503932	Smith & Nephew, Inc.	Memphis, TN, US
1720929	ISOMEDIX OPERATIONS INC.	Sandy, UT, US
3011500362	SPITREX ORTHOPEDICS SWITZERLAND SA	Le Locle Neuchatel, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005893246. Last updated year: 2026. Please use registration number 3005893246 when referencing this establishment in official correspondence.