EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS


Device Classification Name

screw, fixation, bone

510(k) Number K992367
Device Name EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS
Applicant
ELECTRO-BIOLOGY, INC.
100 interpace pkwy.
parsippany, 
NJ 
07054

Applicant Contact jonas wilf
Correspondent
ELECTRO-BIOLOGY, INC.
100 interpace pkwy.
parsippany, 
NJ 
07054

Correspodent Contact jonas wilf
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 07/15/1999
Decision Date 09/23/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No