510(k) K080367

ZIMMER MIS LIGHT by Zimmer Spine, Inc. — Product Code FST

K080367 is an FDA 510(k) premarket notification submitted by Zimmer Spine, Inc. for the device "ZIMMER MIS LIGHT". The FDA issued a decision of Substantially Equivalent on February 22, 2008. The device falls under product code FST (Light, Surgical, Fiberoptic), a Class II device regulated under 21 CFR 878.4580. Zimmer Spine, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2008
Date Received
February 12, 2008
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