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Novosource, LLC: FDA-registered device maker in Morgantown, WV, United States, 4 510(k) clearances

Name: Novosource, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Novosource, LLC is registered with the FDA (registration 3014273644) in Morgantown, WV, United States. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 27, 2014. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3014273644
Address: 1000 Hampton CTR Ste A, Morgantown, WV, United States, 26505
Owner or operator: NovoSource LLC (10056859)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: January 23, 2018
Registered through: 2026
Brand names listed: NovoSource Hip System, NovoSource Knee System, NovoSource Total Hip System

Devices it lists

Device	Product code	Class	Role	Source
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	OQG	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	LZO	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	LPH	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	JWH	2	Complaint file establishment, Manufacturer, 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
June 27, 2014	K140701	NOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E LINER/ BONE SCREWS/ HOLE PLUG	OQG	Substantially Equivalent	Novosource, Inc.	accessdata.fda.gov
February 21, 2014	K132158	NOVOHIP TOTAL HIP SYSTEM	LPH	Substantially Equivalent	Novosource, Inc.	accessdata.fda.gov
September 16, 2013	K131398	NOVOKNEE TOTAL KNEE SYSTEM	JWH	Substantially Equivalent	Novosource, Inc.	accessdata.fda.gov
April 11, 2013	K123339	TK1 TOTAL KNEE SYSTEM	JWH	Substantially Equivalent	Novosource, Inc.	accessdata.fda.gov

Compare with other makers

Updated June 27, 2014. 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.