The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Pyramid +4 Anterior Lumbar Spine Plate System.
| Device ID | K071416 |
| 510k Number | K071416 |
| Device Name: | PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Christine Scifert |
| Correspondent | Christine Scifert MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-21 |
| Decision Date | 2007-11-01 |
| Summary: | summary |