510(k) K933108

TITAN TROCHANTERO-DIAHYSEAL TOTAL HIP PROSTHESIS by Landos, Inc. — Product Code LZO

K933108 is an FDA 510(k) premarket notification submitted by Landos, Inc. for the device "TITAN TROCHANTERO-DIAHYSEAL TOTAL HIP PROSTHESIS". The FDA issued a decision of Substantially Equivalent on September 12, 1994. The device falls under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented), a Class II device regulated under 21 CFR 888.3353. Landos, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1994
Date Received
June 25, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type