The following data is part of a premarket notification filed by Medtronic Sofamor Danck Usa, Inc. with the FDA for Anatomic Peek Cervical Fusion System.
| Device ID | K112444 |
| 510k Number | K112444 |
| Device Name: | ANATOMIC PEEK CERVICAL FUSION SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | MEDTRONIC SOFAMOR DANCK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Becky Ronner |
| Correspondent | Becky Ronner MEDTRONIC SOFAMOR DANCK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-24 |
| Decision Date | 2011-11-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994366474 | K112444 | 000 |
| 00613994360595 | K112444 | 000 |
| 00613994360588 | K112444 | 000 |
| 00613994360571 | K112444 | 000 |
| 00613994360564 | K112444 | 000 |
| 00613994360540 | K112444 | 000 |
| 00613994360533 | K112444 | 000 |
| 00613994360526 | K112444 | 000 |
| 00613994360519 | K112444 | 000 |
| 00613994360502 | K112444 | 000 |
| 00613994360496 | K112444 | 000 |
| 00613994360489 | K112444 | 000 |
| 00613994360472 | K112444 | 000 |
| 00613994360465 | K112444 | 000 |
| 00613994360601 | K112444 | 000 |
| 00613994360618 | K112444 | 000 |
| 00613994366467 | K112444 | 000 |
| 00613994366450 | K112444 | 000 |
| 00613994366443 | K112444 | 000 |
| 00613994366436 | K112444 | 000 |
| 00613994366429 | K112444 | 000 |
| 00613994366412 | K112444 | 000 |
| 00613994366405 | K112444 | 000 |
| 00613994366399 | K112444 | 000 |
| 00613994366382 | K112444 | 000 |
| 00613994360656 | K112444 | 000 |
| 00613994360649 | K112444 | 000 |
| 00613994360632 | K112444 | 000 |
| 00613994360625 | K112444 | 000 |
| 00613994360458 | K112444 | 000 |