METHA SHORT STEM HIP SYSTEM


Device Classification Name

prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

510(k) Number K080584
Device Name METHA SHORT STEM HIP SYSTEM
Applicant
AESCULAP IMPLANT SYSTEM, INC.
3773 corporate parkway
center valley, 
PA 
18034

Applicant Contact kathy a racosky
Correspondent
AESCULAP IMPLANT SYSTEM, INC.
3773 corporate parkway
center valley, 
PA 
18034

Correspodent Contact kathy a racosky
Regulation Number 888.3353
Classification Product Code
MEH  
Subsequent Product Codes
KWY   LWJ   LZO  
Date Received 03/03/2008
Decision Date 05/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No