The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Anatomic Peek Ptc Cervical Fusion System.
| Device ID | K133653 |
| 510k Number | K133653 |
| Device Name: | ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Julie Bassett |
| Correspondent | Julie Bassett MEDTRONIC SOFAMOR DANEK 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 | 2013-11-27 |
| Decision Date | 2014-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169412002 | K133653 | 000 |
| 00643169357686 | K133653 | 000 |
| 00643169357655 | K133653 | 000 |
| 00643169357624 | K133653 | 000 |
| 00643169357600 | K133653 | 000 |
| 00643169357594 | K133653 | 000 |
| 00643169357587 | K133653 | 000 |
| 00643169357570 | K133653 | 000 |
| 00643169357556 | K133653 | 000 |
| 00643169357549 | K133653 | 000 |
| 00643169357525 | K133653 | 000 |
| 00643169357518 | K133653 | 000 |
| 00643169357495 | K133653 | 000 |
| 00643169357488 | K133653 | 000 |
| 00643169357464 | K133653 | 000 |
| 00643169357709 | K133653 | 000 |
| 00643169408036 | K133653 | 000 |
| 00643169411999 | K133653 | 000 |
| 00643169411982 | K133653 | 000 |
| 00643169411975 | K133653 | 000 |
| 00643169411968 | K133653 | 000 |
| 00643169411951 | K133653 | 000 |
| 00643169411944 | K133653 | 000 |
| 00643169411937 | K133653 | 000 |
| 00643169411920 | K133653 | 000 |
| 00643169411913 | K133653 | 000 |
| 00643169411906 | K133653 | 000 |
| 00643169411890 | K133653 | 000 |
| 00643169411883 | K133653 | 000 |
| 00643169411876 | K133653 | 000 |
| 00643169411869 | K133653 | 000 |
| 00643169357457 | K133653 | 000 |