FDA.reportPublic FDA data

ADIRA

Primary DI
00193982535636
Brand
ADIRA
Company
GLOBUS MEDICAL, INC.
Model
6264.0100
Device description
ADIRA Plate Inserter, Threaded Shaft
Published
2024-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KWQAppliance, fixation, spinal intervertebral body
MAXIntervertebral fusion device with bone graft, lumbar
OVDIntervertebral fusion device with integrated fixation, lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233735000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233735000ADIRA™ Lateral Plate SystemGlobus Medical, Inc.2024-01-25KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00193982535636PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00193982535636001939825356361939825356360193982535636

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
139105691
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889095205831XEMPLIFI8103.0001S2015-10-10
00889095205848XEMPLIFI8103.0005S2015-10-10
00889095205855XEMPLIFI8103.0010S2015-10-10
00889095205862XEMPLIFI8103.0101S2015-10-10
00889095205879XEMPLIFI8103.0105S2015-10-10
00889095205886XEMPLIFI8103.0110S2015-10-10
00889095205893XEMPLIFI8103.0201S2015-10-10
00889095205909XEMPLIFI8103.0203S2015-10-10
00889095205916XEMPLIFI8103.0208S2015-10-10
00889095205923XEMPLIFI8103.0210S2015-10-10
00889095401820ANTHEM2171.65092171.65092026-09-25
00889095401844ANTHEM2171.65112171.65112026-09-25
00889095401868ANTHEM2171.65132171.65132026-09-25
00889095401882ANTHEM2171.65152171.65152026-09-25
00889095401905ANTHEM2171.65172171.65172026-09-25
00889095401929ANTHEM2171.65192171.65192026-09-25
00889095402285ANTHEM2171.65552171.65552026-09-25
00889095402438ANTHEM2171.65702171.65702026-09-25
00889095402483ANTHEM2171.65752171.65752026-09-25
00889095402537ANTHEM2171.65802171.65802026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B648C29510000Savant Lumbar Interbody Fusion SystemCURITEVA, INC.MAX2026-10-19
M719GLL11403DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-10-19
M719GLL11503DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-10-19
M719GLL11603DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-10-19
00810161900381EARP, 14X25X08 0°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900398EARP, 14X25X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900404EARP, 14X25X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900411EARP, 14X25X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900428EARP, 14X30X08 0°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900435EARP, 14X30X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900442EARP, 14X30X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900459EARP, 14X30X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900466EARP, 14X35X08 0°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900473EARP, 14X35X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900480EARP, 14X35X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900497EARP, 14X35X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900503EARP, 14X40X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900510EARP, 14X40X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900527EARP, 14X40X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900534EARP, 18X30X08 0°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900541EARP, 18X30X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900558EARP, 18X30X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900565EARP, 18X30X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900572EARP, 18X35X08 0°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900589EARP, 18X35X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900596EARP, 18X35X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900602EARP, 18X35X14 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900619EARP, 18X35X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900626EARP, 18X35X14 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900633EARP, 18X40X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16