FDA.reportPublic FDA data

ZSFab Cervical Interbody System

Primary DI
00810136253238
Brand
ZSFab Cervical Interbody System
Company
Zsfab, Inc.
Model
12140800R
Device description
Cervical 12Dx14Wx08Hx0°_R
Published
2025-05-11
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
00810136253238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810136253238008101362532388101362532380810136253238

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle0degree
Depth12Millimeter
Height8Millimeter
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

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Primary DI, Brand, Company table
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00810017915156SABER-XA, Screw Ø5.5 x 22.5ELEVATION SPINE, INC.ODP2026-09-22
00810017915163SABER-XA, Screw Ø5.5 x 27.5ELEVATION SPINE, INC.ODP2026-09-22
07613327503968Aero-CStryker CorporationODP2019-12-18
10888857461819CASCADIA™ Interbody SystemVB Spine LLCODP2019-10-31
10888857461888CASCADIA™ Interbody SystemVB Spine LLCODP2019-10-31
07613327353921Aero-CStryker CorporationODP2018-06-28
07613327353938Aero-CStryker CorporationODP2018-06-28
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