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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Equipment, Traction, Powered
510(k) Number K031862
Device Name SPINERX-LDM
Applicant
Spinerx Technology
6100 Brittmoore Rd.
Bldg. S
Houston,  TX  77041
Applicant Contact HUGHIE WATSON
Correspondent
Spinerx Technology
6100 Brittmoore Rd.
Bldg. S
Houston,  TX  77041
Correspondent Contact HUGHIE WATSON
Regulation Number890.5900
Classification Product Code
ITH  
Date Received06/16/2003
Decision Date 10/31/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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