MAXLOCK


Device Classification Name

plate, fixation, bone

510(k) Number K050868
Device Name MAXLOCK
Applicant
ORTHOHELIX SURGICAL DESIGNS, INC.
5905 fawn lane
cleveland, 
OH 
44141

Applicant Contact edward a kroll
Correspondent
ORTHOHELIX SURGICAL DESIGNS, INC.
5905 fawn lane
cleveland, 
OH 
44141

Correspodent Contact edward a kroll
Regulation Number 888.3030
Classification Product Code
HRS  
Date Received 04/06/2005
Decision Date 05/27/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No