NOVEL TAPERED HIP STEM


Device Classification Name

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

510(k) Number K103479
Device Name NOVEL TAPERED HIP STEM
Applicant
STRYKER CORP
325 corporate drive
mahwah, 
NJ 
07430

Applicant Contact estela celi
Correspondent
STRYKER CORP
325 corporate drive
mahwah, 
NJ 
07430

Correspodent Contact estela celi
Regulation Number 888.3353
Classification Product Code
MEH  
Subsequent Product Codes
JDI   KWL   KWY   KWZ   LPH  
LWJ   LZO  
Date Received 11/26/2010
Decision Date 03/10/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No