SYNTHES 1.5MM TI BROW LIFT SCREW

Screw, Fixation, Intraosseous

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 1.5mm Ti Brow Lift Screw.

Pre-market Notification Details

Device IDK002935
510k NumberK002935
Device Name:SYNTHES 1.5MM TI BROW LIFT SCREW
ClassificationScrew, Fixation, Intraosseous
Applicant SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
ContactThomas M Maguire
CorrespondentThomas M Maguire
SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
Product CodeDZL  
CFR Regulation Number872.4880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-09-21
Decision Date2000-11-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H9804007010 K002935 000

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