OsteoPlan System
510(k) K212570
OsteoPlan System is a medical device (FDA Class II; FDA product code DZJ, Driver, Wire, And Bone Drill, Manual) made by Osteomed, LLC, cleared under FDA 510(k) K212570 on 11 Feb 2022, 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 | NumberK212570 | Date11 Feb 2022 | StatusActive |
Official records
- FDA 510(k) database K212570
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DZJ
- Device class
- Class II
- Regulation
- 21 CFR Part 872.4120
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
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