510(k) K122637

LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999 by Stryker Spine — Product Code FST

K122637 is an FDA 510(k) premarket notification submitted by Stryker Spine for the device "LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999". The FDA issued a decision of Substantially Equivalent on November 1, 2012. The device falls under product code FST (Light, Surgical, Fiberoptic), a Class II device regulated under 21 CFR 878.4580. Stryker Spine has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2012
Date Received
August 29, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Fiberoptic
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type