SYNTHES (USA) 2.0MM TITANIUM T-PLATE


Device Classification Name

plate, cranioplasty, preformed, alterable

510(k) Number K072758
Device Name SYNTHES (USA) 2.0MM TITANIUM T-PLATE
Applicant
SYNTHES (USA)
1301 goshen pkwy
west chester, 
PA 
19380

Applicant Contact andrea m tasker
Correspondent
SYNTHES (USA)
1301 goshen pkwy
west chester, 
PA 
19380

Correspodent Contact andrea m tasker
Regulation Number 882.5320
Classification Product Code
GWO  
Date Received 09/28/2007
Decision Date 12/18/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No