510(k) K173129

PRECICE System by Nuvasive Specialized Orthopedics, Inc. — Product Code HSB

K173129 is an FDA 510(k) premarket notification submitted by Nuvasive Specialized Orthopedics, Inc. for the device "PRECICE System". The FDA issued a decision of Substantially Equivalent on December 1, 2017. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Nuvasive Specialized Orthopedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2017
Date Received
September 29, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type