The following data is part of a premarket notification filed by Lanx, Llc with the FDA for Lanx Posterior Cervicothoracic Spinal Fixation System (pcfs).
Device ID | K103040 |
510k Number | K103040 |
Device Name: | LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | LANX, LLC 390 INTERLOCKEN CRESCENT SUITE 890 Broomfield, CO 80021 |
Contact | Damon Belloni |
Correspondent | Damon Belloni LANX, LLC 390 INTERLOCKEN CRESCENT SUITE 890 Broomfield, CO 80021 |
Product Code | NKB |
Subsequent Product Code | KWP |
Subsequent Product Code | MNI |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-10-13 |
Decision Date | 2011-02-08 |
Summary: | summary |