FDA.reportPublic FDA data

ZSAlign Cervical Interbody System-Spacer-Wedge

Primary DI
00810216325954
Brand
ZSAlign Cervical Interbody System-Spacer-Wedge
Company
Zsfab, Inc.
Model
ZSAC16180507-M
Catalog number
ZSAC16180507-M
Device description
ZSAlign-C Spacer, Wedge, 16Dx18Wx05Hx07°-M
Published
2026-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K261451000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K261451000ZSAlign Cervical Interbody SystemZSFab, Inc.2026-07-31OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810216325954PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810216325954008102163259548102163259540810216325954

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.

Regulatory Flags#

DUNS number
105224126
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00810216325961ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16180507-HZSAC16180507-H2026-08-17
00810216325978ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16180607-LZSAC16180607-L2026-08-17
00810216325985ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16180607-MZSAC16180607-M2026-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810216325442ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325466ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325800ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325817ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325824ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325831ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325848ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325855ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325862ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325879ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325886ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325893ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325909ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325916ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325923ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325930ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325947ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325961ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325978ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325985ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325992ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216326005ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216326012ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216326029ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216326036ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216326043ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216326050ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216326067ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216326074ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216326081ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17