SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS

Nail, Fixation, Bone

SYNTHES (USA)

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

Pre-market Notification Details

Device IDK111667
510k NumberK111667
Device Name:SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS
ClassificationNail, Fixation, Bone
Applicant SYNTHES (USA) 1301 GOSHEN PKWY. West Chester,  PA  19380
ContactChristopher Hack
CorrespondentChristopher Hack
SYNTHES (USA) 1301 GOSHEN PKWY. West Chester,  PA  19380
Product CodeJDS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-06-14
Decision Date2011-12-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H679030104400 K111667 000
10886982347473 K111667 000
H679030104300 K111667 000
H679030104350 K111667 000
H679030104360 K111667 000
H67903010437S0 K111667 000
H67903010438S0 K111667 000
H679030104410 K111667 000
H679030104420 K111667 000
H679030104550 K111667 000
H679030104560 K111667 000
H679030104330 K111667 000
H679030104340 K111667 000
10886982347466 K111667 000

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