510(k) K223719
K223719 is an FDA 510(k) premarket notification submitted by Aegis Spine, Inc. for the device "Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System". The FDA issued a decision of Substantially Equivalent on Jan 11, 2023. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Aegis Spine, Inc. has 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 11, 2023
- Date Received
- Dec 12, 2022
- 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)