The following data is part of a premarket notification filed by Lanx, Llc with the FDA for Lanx Fusion System.
Device ID | K102738 |
510k Number | K102738 |
Device Name: | LANX FUSION SYSTEM |
Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
Applicant | LANX, LLC 390 INTERLOCKEN CRESCENT SUITE 890 Broomfield, CO 80021 |
Contact | Alan Burkholder |
Correspondent | Alan Burkholder LANX, LLC 390 INTERLOCKEN CRESCENT SUITE 890 Broomfield, CO 80021 |
Product Code | OVD |
Subsequent Product Code | MAX |
Subsequent Product Code | MQP |
Subsequent Product Code | ODP |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-09-22 |
Decision Date | 2011-02-10 |
Summary: | summary |