SYNTHES 1.3 MM SELF-DRILLING SCREW

Screw, Fixation, Intraosseous

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 1.3 Mm Self-drilling Screw.

Pre-market Notification Details

Device IDK983485
510k NumberK983485
Device Name:SYNTHES 1.3 MM SELF-DRILLING SCREW
ClassificationScrew, Fixation, Intraosseous
Applicant SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
ContactSheri L Musgnung
CorrespondentSheri L Musgnung
SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
Product CodeDZL  
CFR Regulation Number872.4880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-10-05
Decision Date1998-12-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H980400456E0 K983485 000
H980400455E0 K983485 000
H980400454E0 K983485 000

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