OSSE-LIGN


Device Classification Name

cerclage, fixation

510(k) Number K023564
Device Name OSSE-LIGN
Original Applicant
OSSEUS, LLC
34 woodlane rd.
lawrenceville, 
NJ 
08648

Original Contact shawn t huxel
Regulation Number 888.3010
Classification Product Code
JDQ  
Date Received 10/23/2002
Decision Date 03/11/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No