510(k) K200224
K200224 is an FDA 510(k) premarket notification submitted by Indius Medical Technologies Pvt. , Ltd. for the device "SEA-LINK Anterior Cervical Plate System". The FDA issued a decision of Substantially Equivalent on Mar 24, 2020. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Indius Medical Technologies Pvt. , Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 24, 2020
- Date Received
- Jan 29, 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)