FDA.reportPublic FDA data

CONCORDE® ProTi 360°™

Primary DI
00819917020892
Brand
CONCORDE® ProTi 360°™
Company
Tyber Medical, LLC
Model
188823213
Catalog number
188823213
Published
2018-04-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MAXIntervertebral fusion device with bone graft, lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172185000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172185000Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC2017-12-21ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819917020892PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819917020892008199170208928199170208920819917020892

GMDN Terms#

Term, Definition table
TermDefinition
Metal-polymer composite spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of a non-bioabsorbable synthetic polymer with a metallic coating that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
010968002
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00196449021178VOLT™ Wrist Treatment System04.426.6452026-04-10
00196449021185VOLT™ Wrist Treatment System02.426.6462026-04-10
00196449021192VOLT™ Wrist Treatment System02.426.6472026-04-10
00196449021208VOLT™ Wrist Treatment System04.426.6462026-04-10
00196449021215VOLT™ Wrist Treatment System04.426.6472026-04-10
00196449021222VOLT™ Wrist Treatment System02.426.2502026-04-10
00196449021239VOLT™ Wrist Treatment System02.426.2552026-04-10
00196449021246VOLT™ Wrist Treatment System02.426.2602026-04-10
00196449021253VOLT™ Wrist Treatment System04.426.2502026-04-10
00196449021260VOLT™ Wrist Treatment System04.426.2552026-04-10
00196449021277VOLT™ Wrist Treatment System04.426.2602026-04-10
00196449021888VOLT™ Wrist Treatment System02.426.7332026-04-10
00196449021895VOLT™ Wrist Treatment System02.426.7322026-04-10
00196449021901VOLT™ Wrist Treatment System04.426.7332026-04-10
00196449021918VOLT™ Wrist Treatment System04.426.7322026-04-10
00196449021925VOLT™ Wrist Treatment System02.426.9112026-04-10
00196449021932VOLT™ Wrist Treatment System02.426.9102026-04-10
00196449021949VOLT™ Wrist Treatment System02.426.9212026-04-10

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00197157076061ZAVATION DISTRACTORZavation LLCMAX2026-05-28
00197157075859ZAVATION INSERTERZavation LLCMAX2026-05-27
00810166522366X-PACEXPANDING INNOVATIONS, INC.MAX2026-05-27
00810166522373X-PACEXPANDING INNOVATIONS, INC.MAX2026-05-27
B70712535005S0Dual X Graft Tamp ShortAMPLIFY SURGICAL, INC.MAX2026-05-27
B707129410010130DUALXS T/PLIF 15 DEG x 9-12MMAMPLIFY SURGICAL, INC.MAX2026-05-27
B707129410010200DUALXS T/PLIF 18 DEG x 10-13MMAMPLIFY SURGICAL, INC.MAX2026-05-27
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