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Medtronic Spine LLC

Matched from indexed company URL: MEDTRONIC SPINE LLC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
29537693002598640Medtronic Spine LLC1N2020-04-25540 Oakmead Parkway Sunnyvale CA US 94085

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
834731549180464K981251KYPHON INFLATABLE BONE TAMPHRX1998-07-02
834731073960990K181864Polaris RF Ablation SystemGXD2019-01-02
834731578978165K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsOLO2017-04-14
834731496815586K163032Kyphon Xpede Bone CementNDN2017-02-27
834732047924708K160983Kyphon HV-R Bone CementNDN2016-08-24
834731641246884K151532KYPHON ELEMENT Inflatable Bone TampHRX2015-07-23
834731079512583K151227KYPHON XPEDE Bone CementNDN2015-11-16
834731729873954K150460KYPHON (R) HV-R(R) Bone CementNDN2015-04-28
834731261390516K123771KYPHON EXPRESS II INFLATABLE BONE TAMPSHRX2012-12-21
834731862314530K103231KYPHON INFLATION SYRINGEHRX2011-01-24
834731429938612K102397KYPHON XPEDE BONE CEMENTNDN2011-02-28
834731939178246K101864KYPHON XPANDER II INFLATABLE BONE TAMPHRX2010-10-14
834731666937496K101765KYPHON ANCHOR FACET SCREW SYSTEMMRW2010-10-22
834731634922505K051123CALLOS IMPACT AND INJECT BONE VOID FILLERMQV2005-06-03
834731328601542K043500FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) SYSTEM, INCLUDING FAD CATHETER KIT AND FAD INTRODUCER NEEDLEBSP2005-04-15
834731621725040K033801KYPHX HV-R, MODEL C01ANDN2004-04-01
834731511064764K032840ATRION MEDICAL QL INFLATION DEVICEKOE2004-03-03
834731022908833K011811MONARCH INFLATION SYRINGE; UNIVERSAL FLUID DISPENSING SYRINGEDXT2001-08-22
834731038953879
834731143063697
834731147553981
834731160966133
834731286923865
834731293757974
834731529301254
834731669083042
834731754659795
834731841235076
834731849143509
834731878930310
834731982090110
834732039530287

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NDN62017-02-27
HRX52015-07-23
GXD12019-01-02
OLO12017-04-14
MRW12010-10-22
MQV12005-06-03
BSP12005-04-15
KOE12004-03-03
DXT12001-08-22

PMN#