510(k) K920968

INFINITY(R) COLLARLESS/MICROTAPER TROCHANTERIC MOD by Dow Corning Wright — Product Code LZO

K920968 is an FDA 510(k) premarket notification submitted by Dow Corning Wright for the device "INFINITY(R) COLLARLESS/MICROTAPER TROCHANTERIC MOD". The FDA issued a decision of Substantially Equivalent on May 5, 1993. 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. Dow Corning Wright has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1993
Date Received
March 2, 1992
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