510(k) K932017

TECHMEDICA CONTINUUM HIP WITH HA COATING by Techmedica, Inc. — Product Code MEH

K932017 is an FDA 510(k) premarket notification submitted by Techmedica, Inc. for the device "TECHMEDICA CONTINUUM HIP WITH HA COATING". The FDA issued a decision of Substantially Equivalent on September 1, 1994. The device falls under product code MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate), 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
September 1, 1994
Date Received
April 26, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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