510(k) K901687

F-24 FEMORAL HIP PROSTHESIS by Med-Tek Corp. — Product Code LWJ

K901687 is an FDA 510(k) premarket notification submitted by Med-Tek Corp. for the device "F-24 FEMORAL HIP PROSTHESIS". The FDA issued a decision of Substantially Equivalent on September 7, 1990. The device falls under product code LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented), a Class II device regulated under 21 CFR 888.3360. Med-Tek Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 1990
Date Received
April 12, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Device Class
Class II
Regulation Number
888.3360
Review Panel
OR
Submission Type