510(k) K072298

BIOPRO MEMORY STAPLE, MODELS 18062-18073 by Biopro, Inc. — Product Code JDR

K072298 is an FDA 510(k) premarket notification submitted by Biopro, Inc. for the device "BIOPRO MEMORY STAPLE, MODELS 18062-18073". The FDA issued a decision of Substantially Equivalent on October 29, 2007. The device falls under product code JDR (Staple, Fixation, Bone), 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 29, 2007
Date Received
August 17, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type