The following data is part of a premarket notification filed by Depuy Acromed with the FDA for Moss Miami 5.5mm Titanium Pin Nut.
| Device ID | K010742 |
| 510k Number | K010742 |
| Device Name: | MOSS MIAMI 5.5MM TITANIUM PIN NUT |
| Classification | Orthosis, Spondylolisthesis Spinal 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 | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-13 |
| Decision Date | 2001-04-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034033501 | K010742 | 000 |