SYNTHES 4.0 AND 5.0 MM LOCKING SCREWS

Screw, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 4.0 And 5.0 Mm Locking Screws.

Pre-market Notification Details

Device IDK000089
510k NumberK000089
Device Name:SYNTHES 4.0 AND 5.0 MM LOCKING SCREWS
ClassificationScrew, Fixation, Bone
Applicant SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
ContactBonnie J Smith
CorrespondentBonnie J Smith
SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-01-12
Decision Date2000-02-03

NIH GUDID Devices

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