The following data is part of a premarket notification filed by Osteomed with the FDA for Osteomed Pinnacle Driver.
| Device ID | K162542 |
| 510k Number | K162542 |
| Device Name: | OsteoMed PINNACLE Driver |
| Classification | Drills, Burrs, Trephines & Accessories (simple, Powered) |
| Applicant | OSTEOMED 3885 ARAPAHO ROAD Addison, TX 75001 |
| Contact | Kathryn A. Jayne |
| Correspondent | Kathryn A. Jayne OSTEOMED 3885 ARAPAHO ROAD Addison, TX 75001 |
| Product Code | HBE |
| CFR Regulation Number | 882.4310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-12 |
| Decision Date | 2017-05-19 |
| Summary: | summary |