FDA.reportPublic FDA data

Tyber Medical

Primary DI
M695302P261288S1
Brand
Tyber Medical
Company
Tyber Medical, LLC
Model
302-P261288-S
Catalog number
302-P261288-S
Device description
PLIF 26mm x 8mm x 12mm x 8 °, PEEK, Sterile
Published
2018-02-02
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
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130573000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130573000TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIFTyber Medical, LLC2013-09-30ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M695302P261288S1PrimaryHIBCC0

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
00196449033393A.L.P.S. mvX™7701030902026-07-23
00196449033409A.L.P.S. mvX™7701070902026-07-23
00196449011735A.L.P.S. mvX™7703000407703000402024-01-20
00196449011742A.L.P.S. mvX™7703000457703000452024-01-20
00196449011759A.L.P.S. mvX™7703000507703000502024-01-20
00196449011766A.L.P.S. mvX™7703000557703000552024-01-20
00196449011773A.L.P.S. mvX™7703000607703000602024-01-20
00196449011780A.L.P.S. mvX™7703000707703000702024-01-20
00196449011797A.L.P.S. mvX™7703520407703520402024-01-20
00196449011803A.L.P.S. mvX™7703520457703520452024-01-20
00196449011810A.L.P.S. mvX™7703520507703520502024-01-20
00196449011827A.L.P.S. mvX™7703520557703520552024-01-20
00196449011834A.L.P.S. mvX™7703520607703520602024-01-20
00196449011841A.L.P.S. mvX™7703520707703520702024-01-20
00196449011858A.L.P.S. mvX™7704010407704010402024-01-20
00196449011865A.L.P.S. mvX™7704010457704010452024-01-20
00196449011872A.L.P.S. mvX™7704010507704010502024-01-20
00196449011889A.L.P.S. mvX™7704010557704010552024-01-20
00196449011896A.L.P.S. mvX™7704010607704010602024-01-20
00196449011902A.L.P.S. mvX™7704010707704010702024-01-20

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017914548Saber-C Body (PT), 14x17x6 12 deg.ELEVATION SPINE, INC.ODP2026-07-23
00810017914555Saber-C Body (PT), 14x17x8 12 deg.ELEVATION SPINE, INC.ODP2026-07-23
00810017914562Saber-C Body (PT), 14x17x7 12 deg.ELEVATION SPINE, INC.ODP2026-07-23
00810017914579Saber-C Body (PT), 14x17x9 12 deg.ELEVATION SPINE, INC.ODP2026-07-23
00810017914586Saber-C Body (PT), 14x17x10 12 deg.ELEVATION SPINE, INC.ODP2026-07-23
00810017914647Saber-C Plate, 14x17x10 12 deg.ELEVATION SPINE, INC.ODP2026-07-23
00843511102579Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-07-23
00843511102579Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-07-23
00843511102135Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102135Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
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00843511102159Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102159Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102166Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102166Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102173Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102173Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102180Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102180Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102197Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102197Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102203Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102203Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102210Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102210Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102227Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102227Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102234Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102234Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22