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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name orthosis, spondylolisthesis spinal fixation
510(k) Number K994288
Device Name 5.0MM SPINAL SCREWS
Applicant
ORTHOTEC, L.L.C.
200 GREGORY LN.
SUITE C-100
PLEASANT HILL,  CA  94523 -3389
Applicant Contact DAVID W SCHLERF
Correspondent
ORTHOTEC, L.L.C.
200 GREGORY LN.
SUITE C-100
PLEASANT HILL,  CA  94523 -3389
Correspondent Contact DAVID W SCHLERF
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   KWQ   MNI  
Date Received12/20/1999
Decision Date 04/10/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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