TWINFIX FT PK


Device Classification Name

screw, fixation, bone

510(k) Number K072785
Device Name TWINFIX FT PK
Applicant
SMITH & NEPHEW INC., ENDOSCOPY DIVISION
150 minuteman rd.
andover, 
MA 
01810

Applicant Contact deana boushell
Correspondent
SMITH & NEPHEW INC., ENDOSCOPY DIVISION
150 minuteman rd.
andover, 
MA 
01810

Correspodent Contact deana boushell
Regulation Number 888.3040
Classification Product Code
HWC  
Subsequent Product Codes
JDR   MBI  
Date Received 10/01/2007
Decision Date 12/10/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No