SONOMA FASTRAC CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA FASTRAC XXYYY(X=DIA, YYY=LENGTH- IN MM)


Device Classification Name

rod, fixation, intramedullary and accessories

510(k) Number K111550
Device Name SONOMA FASTRAC CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA FASTRAC XXYYY(X=DIA, YYY=LENGTH- IN MM)
Applicant
SONOMA ORTHOPEDIC PRODUCTS, INC.
3589 westwind blvd
santa rosa, 
CA 
95403

Applicant Contact charles l nelson
Correspondent
SONOMA ORTHOPEDIC PRODUCTS, INC.
3589 westwind blvd
santa rosa, 
CA 
95403

Correspodent Contact charles l nelson
Regulation Number 888.3020
Classification Product Code
HSB  
Date Received 06/03/2011
Decision Date 08/19/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No