IFS PROFILE PLATES, SCREWS, AND WASHERS


Device Classification Name

plate, fixation, bone

510(k) Number K110086
Device Name IFS PROFILE PLATES, SCREWS, AND WASHERS
Applicant
INTERNAL FIXATION SYSTEMS, INC.
10100 n.w. 116th way, ste. 18
miami, 
FL 
33178

Applicant Contact chris endara
Correspondent
INTERNAL FIXATION SYSTEMS, INC.
10100 n.w. 116th way, ste. 18
miami, 
FL 
33178

Correspodent Contact chris endara
Regulation Number 888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HWC   NDG  
Date Received 01/12/2011
Decision Date 09/09/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No