510(k) K183094
K183094 is an FDA 510(k) premarket notification submitted by Cycla Orthopedics, Ltd. for the device "CyclaPlex Correction System". The FDA issued a decision of Substantially Equivalent on Apr 26, 2019. The device falls under product code HTN (Washer, Bolt Nut), a Class II device regulated under 21 CFR 888.3030.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 26, 2019
- Date Received
- Nov 7, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Washer, Bolt Nut
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type
- 510(k)