FDA.reportPublic FDA data

ZSFab Cervical Interbody System

Primary DI
00850035165041
Brand
ZSFab Cervical Interbody System
Company
Zsfab, Inc.
Model
12141000
Device description
Cervical 12Dx14Wx10HX0°
Published
2022-12-01
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
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
K202488000
K242734000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202488000ZSFab Cervical Interbody SystemZsfab, Inc.2021-01-07ODP
K242734000ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab2024-11-07ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850035165041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850035165041008500351650418500351650410850035165041

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 typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped 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 packaged with the cage.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle0degree
Depth12Millimeter
Height10Millimeter
Width14Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
105224126
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810136254204ZSFab Customized PLIF Instrument JZM1000012026-04-30
00810136254211ZSFab Customized PLIF Instrument JZM1000022026-04-30
00810136254228ZSFab Customized PLIF Instrument YZM1001042026-04-30
00810136254235ZSFab Customized PLIF Instrument YZM1001272026-04-30
00810136254242ZSFab Customized PLIF Instrument YZM1001032026-04-30
00810136254259ZSFab Customized PLIF Instrument YZM1001252026-04-30
00810136254266ZSFab Customized PLIF Instrument YZM1010382026-04-30
00810136254273ZSFab Customized PLIF Instrument YZM1010402026-04-30
00810136254280ZSFab Customized PLIF Instrument YZM1010422026-04-30
00810136254297ZSFab Customized PLIF Instrument YZM1010442026-04-30
00810136254303ZSFab Customized PLIF Instrument YZM1010252026-04-30
00810136254310ZSFab Customized PLIF Instrument YZM1010262026-04-30
00810136254327ZSFab Customized PLIF Instrument YZM1010272026-04-30
00810136254334ZSFab Customized PLIF Instrument YZM1010282026-04-30
00810136254341ZSFab Customized PLIF Instrument YZM1010292026-04-30
00810136254358ZSFab Customized PLIF Instrument YZM1010012026-04-30
00810136254365ZSFab Customized PLIF Instrument YZM1010022026-04-30
00810136254372ZSFab Customized PLIF Instrument YZM1010032026-04-30
00810136254389ZSFab Customized PLIF Instrument YZM1010072026-04-30
00810136254396ZSFab Customized PLIF Instrument YZM1010082026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640221370419SCARLET® AC-TiSpineArt SAODP2025-11-10
07640221370464SCARLET® AC-TiSpineArt SAODP2025-11-10
07640221370471SCARLET® AC-TiSpineArt SAODP2025-11-10
07640164849645icotec Cervical Cage, Cervical Cage Anatomic, Container, completeicotec AGODP2025-06-02
07640164849652icotec Cervical Cage, Cervical Cage Anatomic, Container Baseicotec AGODP2025-06-02
07640164849669icotec Cervical Cage, Cervical Cage Anatomic, Container Lidicotec AGODP2025-06-02
07640164849676icotec Cervical Cage, Cervical Cage Anatomic, Container Rackicotec AGODP2025-06-02
07640332477991SCARLET® AC-TiSpineArt SAODP2024-08-05
07640332478004SCARLET® AC-TiSpineArt SAODP2024-08-05
07640332478011SCARLET® AC-TiSpineArt SAODP2024-08-05
07640332477984SCARLET® AC-TiSpineArt SAODP2024-08-02
07640332478684SCARLET® AC-TiSpineArt SAODP2024-08-02
07640332478691SCARLET® AC-TiSpineArt SAODP2024-08-02
07640332478707SCARLET® AC-TiSpineArt SAODP2024-08-02
07640332478714SCARLET® AC-TiSpineArt SAODP2024-08-02
07640332478721SCARLET® AC-TiSpineArt SAODP2024-08-02
07640332478738SCARLET® AC-TiSpineArt SAODP2024-08-02
07640332478745SCARLET® AC-TiSpineArt SAODP2024-08-02
07640172551400icotec Cervical Cage, Inserter Sleeve, longicotec AGODP2021-09-01
07640172551417icotec Cervical Cage, Inserter Rod, longicotec AGODP2021-09-01
07640185341760SCARLET® AC-T Secured Anterior Cervical CageSpineArt SAODP2019-03-08
07640185341784SCARLET® AC-T Secured Anterior Cervical CageSpineArt SAODP2019-03-08
07640185341807SCARLET® AC-T Secured Anterior Cervical CageSpineArt SAODP2019-03-08
07640185341746SCARLET® AC-T Secured Anterior Cervical CageSpineArt SAODP2019-03-07
07640140433363icotec Lumbar Cage, Slotted Hammericotec AGODP2018-07-16
07640140433783icotec Cervical Cage, Cervical Cage Anatomic, Container, completeicotec AGODP2018-07-16
07640140433790icotec Cervical Cage, Cervical Cage Anatomic, Container Baseicotec AGODP2018-07-16
07640140433806icotec Cervical Cage, Cervical Cage Anatomic, Container Lidicotec AGODP2018-07-16
07640140433813icotec Cervical Cage, Anatomic Probe, 5 mm x 13 mmicotec AGODP2018-07-16
07640140433820icotec Cervical Cage, Anatomic Probe, 6 mm x 13 mmicotec AGODP2018-07-16