510(k) K150851
K150851 is an FDA 510(k) premarket notification submitted by Precision Spine, Inc. for the device "Sure Lok Mini Posterior Cervical/Upper Thoracic System". The FDA issued a decision of Substantially Equivalent on June 4, 2015. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Precision Spine, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 4, 2015
- Date Received
- March 31, 2015
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Appliance, Fixation, Spinal Interlaminal
- Device Class
- Class II
- Regulation Number
- 888.3050
- Review Panel
- OR
- Submission Type