PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHOR


Device Classification Name

screw, fixation, bone

510(k) Number K111000
Device Name PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHOR
Applicant
PARCUS MEDICAL, LLC
839 south neenah ave.
sturgeon bay, 
WI 
54235

Applicant Contact barton bracy
Correspondent
PARCUS MEDICAL, LLC
839 south neenah ave.
sturgeon bay, 
WI 
54235

Correspodent Contact barton bracy
Regulation Number 888.3040
Classification Product Code
HWC  
Subsequent Product Code
MBI  
Date Received 04/11/2011
Decision Date 07/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No