SBI SR MTP TOE IMPLANT


Device Classification Name

prosthesis, toe, hemi-, phalangeal

510(k) Number K073635
Device Name SBI SR MTP TOE IMPLANT
Applicant
SMALL BONE INNOVATIONS INC.
1331 h street nw, 12th fl
washington, 
DC 
20005

Applicant Contact jeffrey zigler
Correspondent
SMALL BONE INNOVATIONS INC.
1331 h street nw, 12th fl
washington, 
DC 
20005

Correspodent Contact jeffrey zigler
Regulation Number 888.3730
Classification Product Code
KWD  
Date Received 12/26/2007
Decision Date 03/19/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No