FDA.reportPublic FDA data

restor3d Cervical Cage

Primary DI
00840097500379
Brand
restor3d Cervical Cage
Company
Restor3d, Inc.
Model
1110-14110507
Device description
Titanium (Ti-6Al-4V) Cervical Cage, 14Wx11Dx5Hx7
Published
2021-03-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191812000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191812000ADI Cervical Interbody Fusion DeviceAdditive Device, Inc. (Adi) D/B/A Restor3D2019-10-24ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840097500379PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097500379008400975003798400975003790840097500379

GMDN Terms#

Term, Definition table
TermDefinition
Metallic 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 metal [e.g., titanium (Ti)] 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
080819836
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840097534237Kinos Aeros Total Ankle Replacement1844-01022026-07-31
00840097534244Kinos Aeros Total Ankle Replacement1844-01042026-07-31
00840097534251Kinos Aeros Total Ankle Replacement1844-01062026-07-31
00840097534268Kinos Aeros Total Ankle Replacement1844-02042026-07-31
00840097534275Kinos Aeros Total Ankle Replacement1844-02062026-07-31
00840097534282Kinos Aeros Total Ankle Replacement1844-02082026-07-31
00840097536552iTotal Identity CR 3DP Porous5200-39322026-07-31
00840097536569iTotal Identity CR 3DP Porous5200-39352026-07-31
00840097536576iTotal Identity CR 3DP Porous5200-39382026-07-31
00840097536583iTotal Identity CR 3DP Porous5200-39412026-07-31
00840097536590iTotal Identity CR 3DP Porous5200-39442026-07-31
00840097513119Veritas Reverse Total Shoulder6500-90012026-07-24
00840097513126Veritas Reverse Total Shoulder6500-90022026-07-24
00840097513133Veritas Reverse Total Shoulder6500-90032026-07-24
00840097516004Veritas Reverse Total Shoulder1500-9001-P012026-07-24
00840097516011Veritas Reverse Total Shoulder1500-9001-P022026-07-24
00840097534206Velora Acetabular System Instrumentation5900-00052026-07-23
00840097534923Veritas Instrumentation6203-10022026-07-23
00840097534930Veritas Instrumentation6500-20602026-07-23
00840097536699Kinos Aeros Instrumentation5801-10002026-07-20

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00843511102661Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102678Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102685Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102692Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
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00843511102739Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102746Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102753Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102760Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102777Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102784Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102791Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102807Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102814Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102821Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102838Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102845Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
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