510(k) K203154
K203154 is an FDA 510(k) premarket notification submitted by Kahtnu Surgical, Inc. for the device "KASILOF Cervical Plate System". The FDA issued a decision of Substantially Equivalent on Nov 5, 2020. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Kahtnu Surgical, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 5, 2020
- Date Received
- Oct 22, 2020
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Appliance, Fixation, Spinal Intervertebral Body
- Device Class
- Class II
- Regulation Number
- 888.3060
- Review Panel
- OR
- Submission Type
- 510(k)