510(k) K800051

HEXCEL FEMORAL COMPONENT HIP PROSTHESIS by Hexcel Medical — Product Code JDG

K800051 is an FDA 510(k) premarket notification submitted by Hexcel Medical for the device "HEXCEL FEMORAL COMPONENT HIP PROSTHESIS". The FDA issued a decision of Substantially Equivalent on January 28, 1980. The device falls under product code JDG (Prosthesis, Hip, Femoral Component, Cemented, Metal), a Class II device regulated under 21 CFR 888.3360. Hexcel Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1980
Date Received
January 9, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Femoral Component, Cemented, Metal
Device Class
Class II
Regulation Number
888.3360
Review Panel
OR
Submission Type