Rti Surgical

FDA Filings

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

FDA Registration(s)

• Registration Number: 3005725110
• FEI Number: 3005725110
• Name: PARADIGM SPINE, LLC
• Owner & Operator: RTI Surgical
• Contact Address: 11621 Research Cir ; Alachua FL 32615 US
• Official Correspondent:
  • Kerry Pearson
  • 1-386-4188888-4111
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 505 Park Avenue 14th Floor; New York, NY 10022 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

• Registration Number: 3005426761
• FEI Number: 3005426761
• Name: Kerry Pearson
• Owner & Operator: RTI Surgical
• Contact Address: 11621 Research Cir ; Alachua FL 32615 US
• Official Correspondent:
  • Kerry Pearson
  • 1-386-4188888-4111
• US Agent:
  • Kerry Pearson
  • 386 4188888 4111
  • HTchamko@rtix.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 11621 Research Cir, Alachua, FL 32615 ; Alachua, FL 32615 US
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMN K153302 | PEK PARADIGM SPINE, LLC [RTI Surgical]	coflex-F+	2016-10-16
PMN K153302 | PEK PARADIGM SPINE, LLC [RTI Surgical]	CoFix	2016-10-16
PMN K153302 | PEK Kerry Pearson [RTI Surgical]	coflex-F+	2016-10-16
PMN K153302 | PEK Kerry Pearson [RTI Surgical]	CoFix	2016-10-16
PMN K112595 | KWP PARADIGM SPINE, LLC [RTI Surgical]	coflex-F	2016-09-01
PMN K112595 | KWP Kerry Pearson [RTI Surgical]	coflex-F	2016-09-01
PMN P110008 | NQO PARADIGM SPINE, LLC [RTI Surgical]	coflex Interlaminar Technology	2013-02-01
PMN P110008 | NQO Kerry Pearson [RTI Surgical]	coflex Interlaminar Technology	2013-02-01
PMN K093438 | KWP PARADIGM SPINE, LLC [RTI Surgical]	cofuse	2010-10-15
PMN K093438 | KWP PARADIGM SPINE, LLC [RTI Surgical]	coflex-f	2010-10-15
PMN K093438 | KWP PARADIGM SPINE, LLC [RTI Surgical]	PIFP	2010-10-15
PMN K093438 | KWP Kerry Pearson [RTI Surgical]	cofuse	2010-10-15
PMN K093438 | KWP Kerry Pearson [RTI Surgical]	coflex-f	2010-10-15
PMN K093438 | KWP Kerry Pearson [RTI Surgical]	PIFP	2010-10-15
PMN K101083 | NQP PARADIGM SPINE, LLC [RTI Surgical]	DSS Stabilization System - Rigid	2010-07-20
PMN K101083 | NQP Kerry Pearson [RTI Surgical]	DSS Stabilization System - Rigid	2010-07-20
PMN K101083 | NKB PARADIGM SPINE, LLC [RTI Surgical]	DSS Stabilization System - Rigid	2010-07-20
PMN K101083 | NKB Kerry Pearson [RTI Surgical]	DSS Stabilization System - Rigid	2010-07-20
PMN K101083 | MNI PARADIGM SPINE, LLC [RTI Surgical]	DSS Stabilization System - Rigid	2010-07-20
PMN K101083 | MNI Kerry Pearson [RTI Surgical]	DSS Stabilization System - Rigid	2010-07-20
PMN K101083 | MNH PARADIGM SPINE, LLC [RTI Surgical]	DSS Stabilization System - Rigid	2010-07-20
PMN K101083 | MNH Kerry Pearson [RTI Surgical]	DSS Stabilization System - Rigid	2010-07-20
PMN K091944 | NQP PARADIGM SPINE, LLC [RTI Surgical]	DSS	2010-01-15
PMN K091944 | NQP Kerry Pearson [RTI Surgical]	DSS	2010-01-15
PMN K091944 | NKB PARADIGM SPINE, LLC [RTI Surgical]	DSS	2010-01-15
PMN K091944 | NKB Kerry Pearson [RTI Surgical]	DSS	2010-01-15
PMN K091944 | MNI PARADIGM SPINE, LLC [RTI Surgical]	DSS	2010-01-15
PMN K091944 | MNI Kerry Pearson [RTI Surgical]	DSS	2010-01-15
PMN K091944 | MNH PARADIGM SPINE, LLC [RTI Surgical]	DSS	2010-01-15
PMN K091944 | MNH Kerry Pearson [RTI Surgical]	DSS	2010-01-15
PMN K090408 | NKB PARADIGM SPINE, LLC [RTI Surgical]	DSS	2010-01-15
PMN K090408 | NKB Kerry Pearson [RTI Surgical]	DSS	2010-01-15
PMN K090408 | MNI PARADIGM SPINE, LLC [RTI Surgical]	DSS	2010-01-15
PMN K090408 | MNI Kerry Pearson [RTI Surgical]	DSS	2010-01-15
PMN K090408 | MNH PARADIGM SPINE, LLC [RTI Surgical]	DSS	2010-01-15
PMN K090408 | MNH Kerry Pearson [RTI Surgical]	DSS	2010-01-15
PMN K090099 | NQP PARADIGM SPINE, LLC [RTI Surgical]	DSS	2010-01-15
PMN K090099 | NQP Kerry Pearson [RTI Surgical]	DSS	2010-01-15
PMN K090099 | NKB PARADIGM SPINE, LLC [RTI Surgical]	DSS	2010-01-15
PMN K090099 | NKB Kerry Pearson [RTI Surgical]	DSS	2010-01-15
PMN K090099 | MNI PARADIGM SPINE, LLC [RTI Surgical]	DSS	2010-01-15
PMN K090099 | MNI Kerry Pearson [RTI Surgical]	DSS	2010-01-15
PMN K090099 | MNH PARADIGM SPINE, LLC [RTI Surgical]	DSS	2010-01-15
PMN K090099 | MNH Kerry Pearson [RTI Surgical]	DSS	2010-01-15
PMN K080241 | NQP PARADIGM SPINE, LLC [RTI Surgical]	DSS	2010-01-15
PMN K080241 | NQP Kerry Pearson [RTI Surgical]	DSS	2010-01-15
PMN K072969 | NQP PARADIGM SPINE, LLC [RTI Surgical]	DSS	2010-01-15
PMN K072969 | NQP Kerry Pearson [RTI Surgical]	DSS	2010-01-15
PMN K080963 | NQP PARADIGM SPINE, LLC [RTI Surgical]	DSS	2008-10-07
PMN K080963 | NQP Kerry Pearson [RTI Surgical]	DSS	2008-10-07

Similar & Related FDA Registered Companies

• RTI Surgical Inc.
• RTI Surgical, Inc. (dba RTI Biologics, Inc.)
• RTI Surgical, Inc. Dba RTI Biologics

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2019080944365	Nagoya Ko ,Japan -> Los Angeles, California	PARTS AND ACCESSORIES FOR USE WITH MACHINE TO OL NEW	1 CRT
2018072048112	Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey	FINANCIAL REPORTS HS CODE: 491110	7 PKG