510(k) K233154
K233154 is an FDA 510(k) premarket notification submitted by Sky Surgical, LLC for the device "SkyOPS Orthopedic Plate System". The FDA issued a decision of Substantially Equivalent on December 21, 2023. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 2023
- Date Received
- September 27, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type