LUCENT MAGNUM
Intervertebral Fusion Device With Integrated Fixation, Lumbar
SPINAL ELEMENTS, INC.
The following data is part of a premarket notification filed by Spinal Elements, Inc. with the FDA for Lucent Magnum.
Pre-market Notification Details
| Device ID | K083475 |
| 510k Number | K083475 |
| Device Name: | LUCENT MAGNUM |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | SPINAL ELEMENTS, INC. 2744 LOKER AVE. W. SUITE 100 Carlsbad, CA 92008 |
| Contact | Kerri Dimartino |
| Correspondent | Kerri Dimartino SPINAL ELEMENTS, INC. 2744 LOKER AVE. W. SUITE 100 Carlsbad, CA 92008 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-24 |
| Decision Date | 2009-02-13 |
| Summary: | summary |
Trademark Results [LUCENT MAGNUM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LUCENT MAGNUM 77552506 3842170 Live/Registered |
Spinal Elements, Inc. 2008-08-21 |
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