510(k) K855017

LSF* TOTAL HIP SYSTEM by Implant Technology, Inc. — Product Code JDI

K855017 is an FDA 510(k) premarket notification submitted by Implant Technology, Inc. for the device "LSF* TOTAL HIP SYSTEM". The FDA issued a decision of SN on June 11, 1986. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Implant Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
June 11, 1986
Date Received
December 16, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device Class
Class II
Regulation Number
888.3350
Review Panel
OR
Submission Type