510(k) K142741

OASYS System by Stryker Corporation — Product Code KWP

K142741 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 January 15, 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
January 15, 2015
Date Received
September 24, 2014
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