EXACTECH EQUINOXE CUFF TEAR ARTHROPLASTY (CTA) HEAD


Device Classification Name

prosthesis, shoulder, non-constrained, metal/polymer cemented

510(k) Number K110706
Device Name EXACTECH EQUINOXE CUFF TEAR ARTHROPLASTY (CTA) HEAD
Applicant
EXACTECH, INC.
2320 n.w. 66th ct.
gainesville, 
FL 
32653

Applicant Contact graham l cuthbert
Correspondent
EXACTECH, INC.
2320 n.w. 66th ct.
gainesville, 
FL 
32653

Correspodent Contact graham l cuthbert
Regulation Number 888.3650
Classification Product Code
KWT  
Subsequent Product Code
HSD  
Date Received 03/14/2011
Decision Date 05/17/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No