The following data is part of a premarket notification filed by Depuy Acromed with the FDA for Monarch Spine System.
| Device ID | K010576 |
| 510k Number | K010576 |
| Device Name: | MONARCH SPINE SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | DEPUY ACROMED 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Frank Maas |
| Correspondent | Frank Maas DEPUY ACROMED 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-27 |
| Decision Date | 2001-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034057804 | K010576 | 000 |
| 10705034057637 | K010576 | 000 |
| 10705034057644 | K010576 | 000 |
| 10705034057651 | K010576 | 000 |
| 10705034057668 | K010576 | 000 |
| 10705034057675 | K010576 | 000 |
| 10705034057682 | K010576 | 000 |
| 10705034057699 | K010576 | 000 |
| 10705034057705 | K010576 | 000 |
| 10705034057712 | K010576 | 000 |
| 10705034057729 | K010576 | 000 |
| 10705034057736 | K010576 | 000 |
| 10705034057743 | K010576 | 000 |
| 10705034057750 | K010576 | 000 |
| 10705034057767 | K010576 | 000 |
| 10705034057774 | K010576 | 000 |
| 10705034057798 | K010576 | 000 |
| 10705034057620 | K010576 | 000 |