ESCALADE ACETABULAR CUP SYSTEM


Device Classification Name

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

510(k) Number K103384
Device Name ESCALADE ACETABULAR CUP SYSTEM
Applicant
ORTHO DEVELOPMENT
12187 s. business park dr.
draper, 
UT 
84020

Applicant Contact tom haueter
Correspondent
ORTHO DEVELOPMENT
12187 s. business park dr.
draper, 
UT 
84020

Correspodent Contact tom haueter
Regulation Number 888.3358
Classification Product Code
LPH  
Subsequent Product Code
LZO  
Date Received 11/18/2010
Decision Date 03/16/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls