ENSPLINT TM BONE SCREW


Device Classification Name

screw, fixation, bone

510(k) Number K080778
Device Name ENSPLINT TM BONE SCREW
Applicant
SONOMA ORTHOPEDIC PRODUCTS, INC.
650 larkfield center
santa rosa, 
CA 
95403

Applicant Contact amy conuel
Correspondent
SONOMA ORTHOPEDIC PRODUCTS, INC.
650 larkfield center
santa rosa, 
CA 
95403

Correspodent Contact amy conuel
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 03/19/2008
Decision Date 07/10/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No