4.0/2.5 MM SELF-DRILLING SCHANZ SCREW


definition

Device Classification Name

pin, fixation, threaded

510(k) Number K002605
Device Name 4.0/2.5 MM SELF-DRILLING SCHANZ SCREW
Original Applicant
SYNTHES (USA)
1690 russell rd.
paoli, 
PA 
19301

Original Contact bonnie j smith
Regulation Number 888.3040
Classification Product Code
JDW  
Date Received 08/22/2000
Decision Date 11/20/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Traditional
Reviewed by Third Party No

Combination Product

No