510(k) K894604

BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT by Biopro, Inc. — Product Code KXA

K894604 is an FDA 510(k) premarket notification submitted by Biopro, Inc. for the device "BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT". The FDA issued a decision of SN on November 17, 1989. The device falls under product code KXA (Prosthesis, Hip, Femoral, Resurfacing), a Class II device regulated under 21 CFR 888.3400. Biopro, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
November 17, 1989
Date Received
July 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Femoral, Resurfacing
Device Class
Class II
Regulation Number
888.3400
Review Panel
OR
Submission Type