510(k) K941534

MODULAR VS-22 CEMENTED FEMORAL HIP SYSTEM by 3M Health Care, Ltd. — Product Code KWY

K941534 is an FDA 510(k) premarket notification submitted by 3M Health Care, Ltd. for the device "MODULAR VS-22 CEMENTED FEMORAL HIP SYSTEM". The FDA issued a decision of Substantially Equivalent on March 6, 1995. The device falls under product code KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented), a Class II device regulated under 21 CFR 888.3390. 3M Health Care, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1995
Date Received
March 30, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Device Class
Class II
Regulation Number
888.3390
Review Panel
OR
Submission Type