OsteoMed PINNACLE Driver
510(k) K162542
OsteoMed PINNACLE Driver is a medical device (FDA Class II; FDA product code HBE, Drills, Burrs, Trephines & Accessories (Simple, Powered)) made by Osteomed, cleared under FDA 510(k) K162542 on 19 May 2017, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK162542 | Date19 May 2017 | StatusActive |
Official records
- FDA 510(k) database K162542
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HBE
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4310
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
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