USS-LINE EXTENSION

Orthosis, Spinal Pedicle Fixation

SYNTHES

The following data is part of a premarket notification filed by Synthes with the FDA for Uss-line Extension.

Pre-market Notification Details

Device IDK010108
510k NumberK010108
Device Name:USS-LINE EXTENSION
ClassificationOrthosis, Spinal Pedicle Fixation
Applicant SYNTHES 1690 RUSSELL RD. P.O. BOX 1766 Paoli,  PA  19301
ContactJonathan Gilbert
CorrespondentJonathan Gilbert
SYNTHES 1690 RUSSELL RD. P.O. BOX 1766 Paoli,  PA  19301
Product CodeMNI  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-01-12
Decision Date2001-06-06

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