OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT


Device Classification Name

implant, temporal

510(k) Number K111069
Device Name OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT
Applicant
OSTEOSYMBIONICS, LLC
p.o. box 560
stillwater, 
MN 
55082

Applicant Contact elaine duncan
Correspondent
OSTEOSYMBIONICS, LLC
p.o. box 560
stillwater, 
MN 
55082

Correspodent Contact elaine duncan
Regulation Number 878.3550
Classification Product Code
MNF  
Date Received 04/18/2011
Decision Date 09/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No