FDA.reportPublic FDA data

Tyber Medical

Primary DI
M695302P229012S1
Brand
Tyber Medical
Company
Tyber Medical, LLC
Model
302-P229012-S
Catalog number
302-P229012-S
Device description
PLIF 22mm x 12mm x 9mm x 0 °, 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
M695302P229012S1PrimaryHIBCC0

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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00196449010134Anatomic Access LLIF818000292026-06-09
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00196449010288Anatomic Access LLIF818000352026-06-09
00196449035243Anatomic Access LLIF818000002026-06-09
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00196449035281Anatomic Access LLIF818000042026-06-09
00196449035298Anatomic Access LLIF818000052026-06-09
00196449035304Anatomic Access LLIF818000062026-06-09
00196449035311Anatomic Access LLIF818000072026-06-09
00196449035328Anatomic Access LLIF818000082026-06-09
00196449035335Anatomic Access LLIF818000092026-06-09
00196449035366Anatomic Access LLIF818000122026-06-09
00196449035380Anatomic Access LLIF818000142026-06-09
00196449035397Anatomic Access LLIF818000152026-06-09
00196449035441Anatomic Access LLIF818000202026-06-09
00196449035465Anatomic Access LLIF818000222026-06-09
00196449035472Anatomic Access LLIF818000232026-06-09

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Primary DI, Brand, Company table
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