The following data is part of a premarket notification filed by Spinal Elements, Inc. with the FDA for Lucent Magnum.
Device ID | K073348 |
510k Number | K073348 |
Device Name: | LUCENT MAGNUM |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | SPINAL ELEMENTS, INC. 2744 LOKER AVE. W. SUITE 100 Carlsbad, CA 92010 |
Contact | Kerri Dimartino |
Correspondent | Kerri Dimartino SPINAL ELEMENTS, INC. 2744 LOKER AVE. W. SUITE 100 Carlsbad, CA 92010 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-11-29 |
Decision Date | 2007-12-26 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
LUCENT MAGNUM 77552506 3842170 Live/Registered |
Spinal Elements, Inc. 2008-08-21 |