510(k) K151553
K151553 is an FDA 510(k) premarket notification submitted by Osteomed Implantes, Ltda for the device "Anterior Cervical Plate System". The FDA issued a decision of Substantially Equivalent on Feb 10, 2016. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Osteomed Implantes, Ltda has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 10, 2016
- Date Received
- Jun 9, 2015
- 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