EQUINOXE REVERSE SHOULDER SYSTEM FRACTURE HUMERAL ADAPTER TRAY AND LOCKING SCREW


Device Classification Name

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

510(k) Number K073688
Device Name EQUINOXE REVERSE SHOULDER SYSTEM FRACTURE HUMERAL ADAPTER TRAY AND LOCKING SCREW
Applicant
EXACTECH, INC.
2320 n.w. 66th ct.
gainesville, 
FL 
32653

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

Correspodent Contact graham cuthbert
Regulation Number 888.3660
Classification Product Code
KWS  
Subsequent Product Code
KWT  
Date Received 12/28/2007
Decision Date 02/29/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls