The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Modificaton To: Pyramid +4 Anterior Lumbar Plate System.
| Device ID | K080429 |
| 510k Number | K080429 |
| Device Name: | MODIFICATON TO: PYRAMID +4 ANTERIOR LUMBAR PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Lila Joe |
| Correspondent | Lila Joe MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-19 |
| Decision Date | 2008-04-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994922946 | K080429 | 000 |
| 00613994286109 | K080429 | 000 |
| 00613994286116 | K080429 | 000 |
| 00613994286123 | K080429 | 000 |
| 00613994286130 | K080429 | 000 |
| 00613994470256 | K080429 | 000 |
| 00613994470263 | K080429 | 000 |
| 00613994470270 | K080429 | 000 |
| 00613994470287 | K080429 | 000 |
| 00613994470294 | K080429 | 000 |
| 00613994922908 | K080429 | 000 |
| 00613994922915 | K080429 | 000 |
| 00613994922922 | K080429 | 000 |
| 00613994922939 | K080429 | 000 |
| 00613994286093 | K080429 | 000 |