Insource Orthopedics L L C

FDA Filings

This page includes the latest FDA filings for Insource Orthopedics L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3005032381
• FEI Number: 3005032381
• Name: Insource Orthopedics, LLC
• Owner & Operator: Insource Orthopedics, LLC
• Contact Address: 15550 Rockfield Blvd Ste D ; Irvine CA 92618 US
• Official Correspondent:
  • Hartmut Loch
  • x-760-7047757-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 15550 Rockfield Blvd Ste D ; Irvine, CA 92618 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMN K120355 | NKB Insource Orthopedics, LLC	Leucadia 4.5 mm Pedicle Screw System	2019-12-30
PMN K120355 | MNI Insource Orthopedics, LLC	Leucadia 4.5 mm Pedicle Screw System	2019-12-30
PMN K120355 | MNH Insource Orthopedics, LLC	Leucadia 4.5 mm Pedicle Screw System	2019-12-30
PMN K120355 | KWQ Insource Orthopedics, LLC	Leucadia 4.5 mm Pedicle Screw System	2019-12-30
PMN K120355 | KWP Insource Orthopedics, LLC	Leucadia 4.5 mm Pedicle Screw System	2019-12-30
PMN K113366 | NKB Insource Orthopedics, LLC	Leucadia AutoLok System	2019-12-30
PMN K113366 | MNI Insource Orthopedics, LLC	Leucadia AutoLok System	2019-12-30
PMN K113366 | MNH Insource Orthopedics, LLC	Leucadia AutoLok System	2019-12-30
PMN K113366 | KWQ Insource Orthopedics, LLC	Leucadia AutoLok System	2019-12-30
PMN K113366 | KWP Insource Orthopedics, LLC	Leucadia AutoLok System	2019-12-30
PMN K112931 | NKB Insource Orthopedics, LLC	Leucadia MIS System	2019-12-30
PMN K112931 | MNI Insource Orthopedics, LLC	Leucadia MIS System	2019-12-30
PMN K112931 | MNH Insource Orthopedics, LLC	Leucadia MIS System	2019-12-30
PMN K112931 | KWQ Insource Orthopedics, LLC	Leucadia MIS System	2019-12-30
PMN K112931 | KWP Insource Orthopedics, LLC	Leucadia MIS System	2019-12-30
PMN K110588 | NKB Insource Orthopedics, LLC	Leucadia Pedicle Screw System	2019-12-30
PMN K110588 | MNI Insource Orthopedics, LLC	Leucadia Pedicle Screw System	2019-12-30
PMN K110588 | MNH Insource Orthopedics, LLC	Leucadia Pedicle Screw System	2019-12-30
PMN K110588 | KWQ Insource Orthopedics, LLC	Leucadia Pedicle Screw System	2019-12-30
PMN K110588 | KWP Insource Orthopedics, LLC	Leucadia Pedicle Screw System	2019-12-30
PMN K070460 | NKB Insource Orthopedics, LLC	Coronado Cross Connectors	2019-12-30
PMN K070460 | MNI Insource Orthopedics, LLC	Coronado Cross Connectors	2019-12-30
PMN K070460 | MNH Insource Orthopedics, LLC	Coronado Cross Connectors	2019-12-30
PMN K070460 | KWQ Insource Orthopedics, LLC	Coronado Cross Connectors	2019-12-30
PMN K070460 | KWP Insource Orthopedics, LLC	Coronado Cross Connectors	2019-12-30
PMN K182339 | NKB Insource Orthopedics, LLC	Leucadia AutoLok System	2019-03-25