510(k) K160363
K160363 is an FDA 510(k) premarket notification submitted by Osteonic Co., Ltd. for the device "OPTIMUS CMF SYSTEM". The FDA issued a decision of Substantially Equivalent on October 20, 2016. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Osteonic Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 20, 2016
- Date Received
- February 9, 2016
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Bone
- Device Class
- Class II
- Regulation Number
- 872.4760
- Review Panel
- DE
- Submission Type