GRAFTON MEDICAL ALLIANCE

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30111953163011195316GRAFTON MEDICAL ALLIANCE1Y2020-04-25241 South Frontage RD Suite #33 Burr Ridge IL US 60527

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1754331229264974K192915GMA 2.0 Pedicle Screw SystemNKB2019-11-13
1754331984372992K173099Fortis and Hana Anterior Cervical Plate SystemKWQ2017-11-30
1754331865996610K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageODP2016-11-21
1754331768456706K133063SANTIS PEDICLE SCREW SYSTEMNKB2014-01-13
1754331006739607K130573TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIFODP2013-09-30
1754331919793065K112533ZAVATION CERVICAL PLATE SYSTEMKWQ2011-12-08
1754331418393713K112484ZAVATION SPINAL SYSTEMMNI2011-11-22
1754331780255743K112025SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEMKWP2011-09-15
1754331624396573K111362REXIOUS SPINAL FIXATION SYSTEMMNH2011-07-21
1754331368131624K103369VAULT ALIF SYSTEMOVD2011-04-04
1754331917381570K080314SPINAL USA INTERBODY FUSION DEVICEMAX2008-05-13

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NKB22019-11-13
KWQ22017-11-30
ODP22016-11-21
MNI12011-11-22
KWP12011-09-15
MNH12011-07-21
OVD12011-04-04
MAX12008-05-13

PMN#