The following data is part of a premarket notification filed by Phygen, Llc with the FDA for Leucadia Pedicle Screw System.
Device ID | K103102 |
510k Number | K103102 |
Device Name: | LEUCADIA PEDICLE SCREW SYSTEM |
Classification | Orthosis, Spinal Pedicle Fixation |
Applicant | PHYGEN, LLC 2301 DUPONT DRIVE SUITE 510 Irvine, CA 92612 |
Contact | Hartmut Loch |
Correspondent | Hartmut Loch PHYGEN, LLC 2301 DUPONT DRIVE SUITE 510 Irvine, CA 92612 |
Product Code | MNI |
Subsequent Product Code | KWP |
Subsequent Product Code | KWQ |
Subsequent Product Code | MNH |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-10-20 |
Decision Date | 2011-02-08 |
Summary: | summary |