The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Premier Anterior Cervical Plate System.
| Device ID | K021761 |
| 510k Number | K021761 |
| Device Name: | PREMIER ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard Trehame |
| Correspondent | Richard Trehame MEDTRONIC SOFAMOR DANEK 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 | 2002-05-29 |
| Decision Date | 2002-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885074229034 | K021761 | 000 |
| 00885074229164 | K021761 | 000 |
| 00885074229171 | K021761 | 000 |
| 00885074229188 | K021761 | 000 |
| 00885074229195 | K021761 | 000 |
| 00885074229201 | K021761 | 000 |
| 00885074229218 | K021761 | 000 |
| 00885074229225 | K021761 | 000 |
| 00885074229232 | K021761 | 000 |
| 00885074229157 | K021761 | 000 |
| 00885074229140 | K021761 | 000 |
| 00885074229133 | K021761 | 000 |
| 00885074229041 | K021761 | 000 |
| 00885074229065 | K021761 | 000 |
| 00885074229072 | K021761 | 000 |
| 00885074229089 | K021761 | 000 |
| 00885074229096 | K021761 | 000 |
| 00885074229102 | K021761 | 000 |
| 00885074229119 | K021761 | 000 |
| 00885074229126 | K021761 | 000 |
| 00885074229249 | K021761 | 000 |
| 00885074229256 | K021761 | 000 |
| 00885074229270 | K021761 | 000 |
| 00721902500381 | K021761 | 000 |
| 00721902500398 | K021761 | 000 |
| 00721902500435 | K021761 | 000 |
| 00721902500459 | K021761 | 000 |
| 00721902688294 | K021761 | 000 |
| 00721902688348 | K021761 | 000 |
| 00721902688362 | K021761 | 000 |
| 00721902710469 | K021761 | 000 |
| 00721902500336 | K021761 | 000 |
| 00721902500329 | K021761 | 000 |
| 00885074231259 | K021761 | 000 |
| 00885074229287 | K021761 | 000 |
| 00885074229294 | K021761 | 000 |
| 00885074229300 | K021761 | 000 |
| 00885074229317 | K021761 | 000 |
| 00885074229324 | K021761 | 000 |
| 00885074229331 | K021761 | 000 |
| 00885074229348 | K021761 | 000 |
| 00885074229355 | K021761 | 000 |
| 00721902710513 | K021761 | 000 |