Orthonovis Inc

FDA Filings

This page includes the latest FDA filings for Orthonovis Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3015946784
• FEI Number: 3015946784
• Name: ORTHONOVIS, INC.
• Owner & Operator: OrthoNovis, Inc.
• Contact Address: 1 Hargrove Grade, 2F ; Palm Coast FL 32137 US
• Official Correspondent:
  • Kyle Firth
  • 1-904-7422450-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1 Hargrove Grade, 2F ; Palm Coast, FL 32137 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMN K213905 OrthoNovis, Inc.	ONX Large External Fixation System	2022-08-25
PMN K130614 | HWC ORTHONOVIS, INC.	OrthoNovis Bone Plate and Screw System	2019-10-28
PMN K130614 | HTN ORTHONOVIS, INC.	OrthoNovis Bone Plate and Screw System	2019-10-28
PMN K130614 | HRS ORTHONOVIS, INC.	OrthoNovis Bone Plate and Screw System	2019-10-28
PMN K130613 | HWC ORTHONOVIS, INC.	OrthoNovis BPSS Cannulated Screws	2019-10-28
PMN K130613 | HTY ORTHONOVIS, INC.	OrthoNovis BPSS Cannulated Screws	2019-10-28
PMN K130613 | HTN ORTHONOVIS, INC.	OrthoNovis BPSS Cannulated Screws	2019-10-28