510(k) K905262

BUECHEL-PAPPAS EXTENDED COLLAR FEMORAL STEM PROSTH by Endotec, Inc. — Product Code JDI

K905262 is an FDA 510(k) premarket notification submitted by Endotec, Inc. for the device "BUECHEL-PAPPAS EXTENDED COLLAR FEMORAL STEM PROSTH". The FDA issued a decision of SN on May 19, 1993. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Endotec, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
May 19, 1993
Date Received
November 23, 1990
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