FDA.report

SpineCraft

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30047173583004717358SPINECRAFT LLC1N2026-01-01777 Oakmont Ln Suite 200 Westmont IL US 60559

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
638871112989521K260015ANTERIS Thoracolumbar Plate SystemKWQ2026-03-04
638871396692661K253260ORIO-3D Cage SystemODP2026-04-16
638871320382538K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemOLO2023-07-20
638871440976051K223273ASTRA Spine SystemNKB2022-12-22
638871361949824K211935ORIO-Ti Intervertebral Body Fusion Cage SystemODP2021-09-30
638871878404126K211323ASTRA Spine SystemNKB2021-06-03
638871129796056K181350ASTRA-OCT Spine SystemNKG2018-07-06
638871250274857K150417ASTRA SPINE SYSTEMNKB2015-05-19
638872006129448K143683APEX-DL Spine SystemNKB2015-05-22
638871176720661K132603APEX SPINE SYSTEMNKB2013-11-20
638871980192228K131521VELOX ANTERIOR CERVICAL PLATE SYSTEMKWQ2013-12-24
638871663520796K113728SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTYMBP2012-11-15
638871022431651K110906APEX SPINE SYSTEMNKB2011-07-26
638871358108923K103505ALTUM ANTERIOR CERVICAL PLATEKWQ2011-03-15
638871367845941K102488APEX SPINE SYSTEM W/ COCR RODSMNH2010-12-10
638871425440010K092825APEX SPINE SYSTEM 5.50 MM TITANIUM ROD & POLYAXIAL SCREW WASHERKWP2010-03-16
638871644071019K090887ORIO-C CERVICAL, ORIO-TL TLIF, ORIO-PL PLIF, ORIO-AL ALIF INTERVEDRTEBRAL BODY FUSION CAGESODP2009-10-30
638871989283338K062513APEX SPINE SYSTEMKWP2006-12-22
638871851739730K062496OSTEOPORE TCPMQV2006-10-19
638871327911921

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
NKB62022-12-22
ODP32026-04-16
KWQ32026-03-04
KWP22010-03-16
OLO12023-07-20
NKG12018-07-06
MBP12012-11-15
MNH12010-12-10
MQV12006-10-19

PMN

GUDID

ORIO

2025-01-30

SPINECRAFT, LLC

ORIO

2025-01-30

SPINECRAFT, LLC

ORIO

2025-01-30

SPINECRAFT, LLC

ORIO

2024-06-15

SPINECRAFT, LLC

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