TREGOR DUAL MOBILITY ACETABULAR SYSTEM


Device Classification Name

prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

510(k) Number K111981
Device Name TREGOR DUAL MOBILITY ACETABULAR SYSTEM
Applicant
ASTON MEDICAL
577 north hope ave
santa barbara, 
CA 
93110

Applicant Contact catherine gloster
Correspondent
ASTON MEDICAL
577 north hope ave
santa barbara, 
CA 
93110

Correspodent Contact catherine gloster
Regulation Number 888.3353
Classification Product Code
LZO  
Subsequent Product Codes
JDI   LPH   MEH  
Date Received 07/12/2011
Decision Date 10/12/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No