MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM

Reamer

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Modification To Synthes (usa) Reamer Irrigator Aspirator (ria) System.

Pre-market Notification Details

Device IDK013527
510k NumberK013527
Device Name:MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM
ClassificationReamer
Applicant SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
ContactBonnie J Smith
CorrespondentBonnie J Smith
SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
Product CodeHTO  
CFR Regulation Number888.4540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-10-23
Decision Date2001-12-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H679351718S0 K013527 000
H679352251S0 K013527 000
H679352252S0 K013527 000
H679352253S0 K013527 000
H679352254S0 K013527 000
H679352255S0 K013527 000
H679352256S0 K013527 000
H679352257S0 K013527 000
H679352258S0 K013527 000
H679352259S0 K013527 000
07611819739192 K013527 000
07611819739208 K013527 000
H679314745S0 K013527 000
H679314746S0 K013527 000
H679352250S0 K013527 000

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