SYNTHES (USA) RESORBABLE TACK SYSTEM

Plate, Bone

SYNTHES (USA)

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

Pre-market Notification Details

Device IDK000560
510k NumberK000560
Device Name:SYNTHES (USA) RESORBABLE TACK SYSTEM
ClassificationPlate, Bone
Applicant SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli,  PA  19301
ContactBonnie J Smith
CorrespondentBonnie J Smith
SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli,  PA  19301
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-02-18
Decision Date2001-01-09

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