510(k) K042034

NUVASIVE MAXCESS LIGHT GUIDE by Nuvasive, Inc. — Product Code FST

K042034 is an FDA 510(k) premarket notification submitted by Nuvasive, Inc. for the device "NUVASIVE MAXCESS LIGHT GUIDE". The FDA issued a decision of Substantially Equivalent on October 26, 2004. The device falls under product code FST (Light, Surgical, Fiberoptic), a Class II device regulated under 21 CFR 878.4580. Nuvasive, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2004
Date Received
July 29, 2004
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