EIS THREADED SCREW FRACTURE FIXATION


Device Classification Name

screw, fixation, bone

510(k) Number K991964
Device Name EIS THREADED SCREW FRACTURE FIXATION
Applicant
GROUPE LEPINE
962 south tamiami trail
suite 203
sarasota, 
FL 
34326

Applicant Contact douglas w stuart
Correspondent
GROUPE LEPINE
962 south tamiami trail
suite 203
sarasota, 
FL 
34326

Correspodent Contact douglas w stuart
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 06/10/1999
Decision Date 12/20/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No