The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Pyramid Anterior Plate Fixation System.
| Device ID | K013665 |
| 510k Number | K013665 |
| Device Name: | PYRAMID ANTERIOR PLATE FIXATION SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard W Treharne |
| Correspondent | Richard W Treharne MEDTRONIC SOFAMOR DANEK, 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 | 2001-11-06 |
| Decision Date | 2002-01-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994116819 | K013665 | 000 |
| 00721902214547 | K013665 | 000 |
| 00721902214523 | K013665 | 000 |
| 00721902214516 | K013665 | 000 |
| 00721902214493 | K013665 | 000 |
| 00721902214486 | K013665 | 000 |
| 00721902214479 | K013665 | 000 |
| 00721902214455 | K013665 | 000 |
| 00721902214448 | K013665 | 000 |
| 00721902214431 | K013665 | 000 |
| 00721902214417 | K013665 | 000 |
| 00721902214394 | K013665 | 000 |
| 00721902214653 | K013665 | 000 |
| 00721902214684 | K013665 | 000 |
| 00721902337611 | K013665 | 000 |
| 00613994116802 | K013665 | 000 |
| 00613994116796 | K013665 | 000 |
| 00613994116789 | K013665 | 000 |
| 00613994116772 | K013665 | 000 |
| 00613994116765 | K013665 | 000 |
| 00721902937057 | K013665 | 000 |
| 00721902937040 | K013665 | 000 |
| 00721902337666 | K013665 | 000 |
| 00721902337659 | K013665 | 000 |
| 00721902337635 | K013665 | 000 |
| 00721902337628 | K013665 | 000 |
| 00721902214363 | K013665 | 000 |