FDA.reportPublic FDA data

SPINAL KINETICS LLC

Matched from indexed company URL: Spinal Kinetics, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30049872823004987282SPINAL KINETICS LLC1N2020-04-25501 Mercury Dr SUNNYVALE CA US 94085

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
646102027628041P170036M6-C Artificial Cervical DiscMJO2019-02-06
646101249492301
646101896639998
646101977815049

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MJO12019-02-06

PMA#

M6-C Artificial Cervical Disc

2022-11-01

Spinal Kinetics LLC501 Mercury Drivesunnyvale, CA 94085 PMA NumberP170036 Supplement NumberS012 Date Received10/17/2022 Decision Date11/01/2022 Product Code MJO  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - M...

M6-C Artificial Cervical Disc

2022-07-01

Spinal Kinetics LLC501 Mercury Drivesunnyvale, CA 94085 PMA NumberP170036 Supplement NumberS011 Date Received06/09/2022 Decision Date07/01/2022 Product Code MJO  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - M...

M6-C Artificial Cervical Disc

2022-04-05

Spinal Kinetics LLC501 Mercury Drivesunnyvale, CA 94085 PMA NumberP170036 Supplement NumberS010 Date Received03/08/2022 Decision Date04/05/2022 Product Code MJO  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - M...

PMN#

GUDID#

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