MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS)


Device Classification Name

neurological stereotaxic instrument

510(k) Number K072806
Device Name MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS)
Applicant
MAKO SURGICAL CORP.
2555 davie rd.
fort lauderdale, 
FL 
33317

Applicant Contact william tapia
Correspondent
MAKO SURGICAL CORP.
2555 davie rd.
fort lauderdale, 
FL 
33317

Correspodent Contact william tapia
Regulation Number 882.4560
Classification Product Code
HAW  
Date Received 10/01/2007
Decision Date 01/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls