510(k) K132510

BIOPRO - INFINITY PLATE ANCHOR SYSTEM by Biopro, Inc. — Product Code HTN

K132510 is an FDA 510(k) premarket notification submitted by Biopro, Inc. for the device "BIOPRO - INFINITY PLATE ANCHOR SYSTEM". The FDA issued a decision of Substantially Equivalent on October 24, 2013. The device falls under product code HTN (Washer, Bolt Nut), a Class II device regulated under 21 CFR 888.3030. Biopro, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2013
Date Received
August 12, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Washer, Bolt Nut
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type