SYNTHES HAMSTRING LOOP

Screw, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Hamstring Loop.

Pre-market Notification Details

Device IDK003700
510k NumberK003700
Device Name:SYNTHES HAMSTRING LOOP
ClassificationScrew, Fixation, Bone
Applicant SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
ContactThomas M Maguire
CorrespondentThomas M Maguire
SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-12-01
Decision Date2001-02-20

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