510(k) K931929

TECHMEDICA CONTINUUM HIP SYSTEM by Techmedica, Inc. — Product Code LZO

K931929 is an FDA 510(k) premarket notification submitted by Techmedica, Inc. for the device "TECHMEDICA CONTINUUM HIP SYSTEM". The FDA issued a decision of Substantially Equivalent on March 29, 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. Techmedica, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1994
Date Received
April 16, 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