EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM


Device Classification Name

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

510(k) Number K103419
Device Name EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM
Applicant
EXACTECH, INC.
2320 n.w. 66th court
gainesville, 
FL 
32653

Applicant Contact patrick hughes
Correspondent
EXACTECH, INC.
2320 n.w. 66th court
gainesville, 
FL 
32653

Correspodent Contact patrick hughes
Regulation Number 888.3660
Classification Product Code
KWS  
Date Received 11/22/2010
Decision Date 12/13/2010
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No