FDA.reportPublic FDA data

ZSFab Cervical Interbody System

Primary DI
00850035165010
Brand
ZSFab Cervical Interbody System
Company
Zsfab, Inc.
Model
12140700
Device description
Cervical 12Dx14Wx07HX0°
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
00850035165010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850035165010008500351650108500351650100850035165010

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
Height7Millimeter
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
00810216325442ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16161010-MZSAC16161010-M2026-08-17
00810216325466ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16161110-LZSAC16161110-L2026-08-17
00810216325800ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16180800-MZSAC16180800-M2026-08-17
00810216325817ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16180800-HZSAC16180800-H2026-08-17
00810216325824ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16180900-LZSAC16180900-L2026-08-17
00810216325831ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16180900-MZSAC16180900-M2026-08-17
00810216325848ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16180900-HZSAC16180900-H2026-08-17
00810216325855ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16181000-LZSAC16181000-L2026-08-17
00810216325862ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16181000-MZSAC16181000-M2026-08-17
00810216325879ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16181000-HZSAC16181000-H2026-08-17
00810216325886ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16181100-LZSAC16181100-L2026-08-17
00810216325893ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16181100-MZSAC16181100-M2026-08-17
00810216325909ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16181100-HZSAC16181100-H2026-08-17
00810216325916ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16181200-LZSAC16181200-L2026-08-17
00810216325923ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16181200-MZSAC16181200-M2026-08-17
00810216325930ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16181200-HZSAC16181200-H2026-08-17
00810216325947ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16180507-LZSAC16180507-L2026-08-17
00810216325954ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16180507-MZSAC16180507-M2026-08-17
00810216325961ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16180507-HZSAC16180507-H2026-08-17
00810216325978ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16180607-LZSAC16180607-L2026-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840311258635C-Plus PEEK IBF SystemXtant Medical Holdings, Inc.ODP2026-08-26
00843511102852Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00843511102869Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00843511102876Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00843511102883Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00843511102890Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00843511102906Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00843511102913Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00843511102920Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00810017913695Saber-C Body (PT), 12x15x10 6 deg.ELEVATION SPINE, INC.ODP2026-08-14
00843511102586Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102593Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102609Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102616Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102623Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102630Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102647Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102654Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
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
00843511102708Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102715Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102722Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
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