SYNTHES (USA) SPHERICAL WASHERS

Washer, Bolt, Nut, Non-spinal, Metallic

SYNTHES (USA)

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

Pre-market Notification Details

Device IDK052483
510k NumberK052483
Device Name:SYNTHES (USA) SPHERICAL WASHERS
ClassificationWasher, Bolt, Nut, Non-spinal, Metallic
Applicant SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester,  PA  19380
ContactLisa M Boyle
CorrespondentLisa M Boyle
SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester,  PA  19380
Product CodeNDG  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-09-09
Decision Date2005-11-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H679219953S0 K052483 000
H679219952S0 K052483 000
H679419953S0 K052483 000

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