SMITH & NEPHEW MIS HIP STEM WITH STIKTITE


Device Classification Name

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

510(k) Number K080625
Device Name SMITH & NEPHEW MIS HIP STEM WITH STIKTITE
Applicant
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis, 
TN 
38116

Applicant Contact rishi sinha
Correspondent
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis, 
TN 
38116

Correspodent Contact rishi sinha
Regulation Number 888.3358
Classification Product Code
LPH  
Date Received 03/05/2008
Decision Date 05/08/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No