The following data is part of a premarket notification filed by Lanx, Llc with the FDA for Lanx Spinal Fixation System.
Device ID | K071877 |
510k Number | K071877 |
Device Name: | LANX SPINAL FIXATION SYSTEM |
Classification | Orthosis, Spinal Pedicle Fixation |
Applicant | LANX, LLC 1835 MARKET STREET, 28TH FLOOR Philadelphia, PA 19102 |
Contact | Janice M Hogan |
Correspondent | Janice M Hogan LANX, LLC 1835 MARKET STREET, 28TH FLOOR Philadelphia, PA 19102 |
Product Code | MNI |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-07-09 |
Decision Date | 2007-09-17 |
Summary: | summary |