GENEROS SB SMALL BONE DISTRACTION IMPLANT


Device Classification Name

appliance, fixation, nail/blade/plate combination, multiple component

510(k) Number K051162
Device Name GENEROS SB SMALL BONE DISTRACTION IMPLANT
Applicant
ORTHONETX, INC.
1000 s. maccaslin blvd.
suite 300
superior, 
CO 
80027

Applicant Contact terry knapp
Correspondent
ORTHONETX, INC.
1000 s. maccaslin blvd.
suite 300
superior, 
CO 
80027

Correspodent Contact terry knapp
Regulation Number 888.3030
Classification Product Code
KTT  
Subsequent Product Code
HRS  
Date Received 05/05/2005
Decision Date 07/19/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No