SL-PLUS STANDARD AND LATERAL HIP STEMS


Device Classification Name

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

510(k) Number K072852
Device Name SL-PLUS STANDARD AND LATERAL HIP STEMS
Applicant
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis, 
TN 
38116

Applicant Contact nicholas b tabrizi
Correspondent
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis, 
TN 
38116

Correspodent Contact nicholas b tabrizi
Regulation Number 888.3353
Classification Product Code
LZO  
Subsequent Product Codes
KWY   LWJ  
Date Received 10/04/2007
Decision Date 06/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No