New Paradigm Biomedical, LLC

FDA Device Registration & Listing · Northborough, MA, US · Registration 3043355196

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
3043355196
FEI Number
3043355196
Entity Name
New Paradigm Biomedical, LLC
City/State/Country
Northborough, MA, US
Establishment Address
2 Stirrup Brook Ln, Northborough, MA 01532, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
NPB Ortho (Owner Number: 10095169)
Owner / Operator Contact Address
8403 w. Buckskin Rd, Pocatello, ID 83201, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K230067
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2026-02-02
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2026-02-02

Official Correspondent

Nephi Zufelt

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NPB Ortho
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043355196. Last updated year: 2026. Please use registration number 3043355196 when referencing this establishment in official correspondence.
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