INTELLIGENT IMPLANT SYSTEMS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30111213673011121367INTELLIGENT IMPLANT SYSTEMS1N2020-04-253300 Intl Airport Dr STE 1100 Charlotte NC US 28208

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1833141929145358K173935Mediant Anterior Cervical Plating SystemKWQ2018-04-16
1833141128846057K163056Revolution™ Spinal Fixation SystemNKB2017-02-24
1833142003091960K160216Revolution Spinal Fixation SystemNKB2016-04-22
1833141999112542K142939Revolution Spinal Fixation SystemNKB2015-01-13

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NKB32017-02-24
KWQ12018-04-16

PMN#

GUDID#

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