PARALLEL-SIDED EXTENSIVELY COATED FEMORAL STEMS


Device Classification Name

prosthesis, hip, semi-constrained (metal uncemented acetabular component)

510(k) Number K073637
Device Name PARALLEL-SIDED EXTENSIVELY COATED FEMORAL STEMS
Applicant
BIOMET MANUFACTURING CORP.
56 east bell drive
p.o. box 587
warsaw, 
IN 
46581 -0587

Applicant Contact elizabeth wray
Correspondent
BIOMET MANUFACTURING CORP.
56 east bell drive
p.o. box 587
warsaw, 
IN 
46581 -0587

Correspodent Contact elizabeth wray
Regulation Number 888.3330
Classification Product Code
KWA  
Subsequent Product Codes
JDI   KWY   KWZ   LPH  
Date Received 12/26/2007
Decision Date 03/20/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No