TENODESIS CROSS SCREW, INTERFERENCE SCREW, SUTURE BEAD


Device Classification Name

fastener, fixation, nondegradable, soft tissue

510(k) Number K081348
Device Name TENODESIS CROSS SCREW, INTERFERENCE SCREW, SUTURE BEAD
Applicant
TRIMED, INC.
25864 tournament rd. suite a
valencia, 
CA 
91355

Applicant Contact kelli anderson
Correspondent
TRIMED, INC.
25864 tournament rd. suite a
valencia, 
CA 
91355

Correspodent Contact kelli anderson
Regulation Number 888.3040
Classification Product Code
MBI  
Subsequent Product Codes
HTY   HWC  
Date Received 05/14/2008
Decision Date 10/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No