UNI HIP STEM


Device Classification Name

prosthesis, hip, semi-constrained, metal/polymer, uncemented

510(k) Number K024134
Device Name UNI HIP STEM
Original Applicant
PLUS ORTHOPEDICS
1001 oakwood blvd.
round rock, 
TX 
78681 -2700

Original Contact j.d. webb
Regulation Number 888.3360
Classification Product Code
LWJ  
Subsequent Product Code
JDI  
Date Received 12/16/2002
Decision Date 01/15/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No