The following data is part of a premarket notification filed by Spinal Elements, Inc. with the FDA for Lotus Posterior Cervical/thoracic Spinal System.
| Device ID | K151705 |
| 510k Number | K151705 |
| Device Name: | Lotus Posterior Cervical/Thoracic Spinal System |
| Classification | Posterior Cervical Screw System |
| Applicant | SPINAL ELEMENTS, INC. 3115 MELROSE DRIVE, STE 200 Carlsbad, CA 92010 |
| Contact | Cecilia Silva |
| Correspondent | Cecilia Silva SPINAL ELEMENTS, INC. 3115 MELROSE DRIVE, STE 200 Carlsbad, CA 92010 |
| Product Code | NKG |
| CFR Regulation Number | 888.3075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-24 |
| Decision Date | 2015-09-03 |
| Summary: | summary |