510(k) K150753
K150753 is an FDA 510(k) premarket notification submitted by Stryker Corporation for the device "OASYS System". The FDA issued a decision of Substantially Equivalent on June 9, 2015. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Stryker Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 9, 2015
- Date Received
- March 23, 2015
- Clearance Type
- Traditional
- 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