510(k) K200523
K200523 is an FDA 510(k) premarket notification submitted by Elite Surgical Supplies (Pty), Ltd. for the device "Biolign® Roto-Loc Cervical Plate System". The FDA issued a decision of Substantially Equivalent on Apr 30, 2020. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Elite Surgical Supplies (Pty), Ltd. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 30, 2020
- Date Received
- Mar 2, 2020
- Clearance Type
- Traditional
- 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)