4.0/2.5 MM SELF-DRILLING SCHANZ SCREW

Pin, Fixation, Threaded

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for 4.0/2.5 Mm Self-drilling Schanz Screw.

Pre-market Notification Details

Device IDK002605
510k NumberK002605
Device Name:4.0/2.5 MM SELF-DRILLING SCHANZ SCREW
ClassificationPin, Fixation, Threaded
Applicant SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
ContactBonnie J Smith
CorrespondentBonnie J Smith
SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
Product CodeJDW  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-08-22
Decision Date2000-11-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H6792947690 K002605 000
H6794947690 K002605 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.