ABG II MONOLITHIC HIP STEM


Device Classification Name

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

510(k) Number K110807
Device Name ABG II MONOLITHIC HIP STEM
Applicant
STRYKER CORP.
325 corporate drive
mahwah, 
NJ 
07430

Applicant Contact stephanie fitts
Correspondent
STRYKER CORP.
325 corporate drive
mahwah, 
NJ 
07430

Correspodent Contact stephanie fitts
Regulation Number 888.3353
Classification Product Code
MAY  
Subsequent Product Codes
LPH   LZO   MBL   MEH  
Date Received 03/23/2011
Decision Date 05/25/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No