FDA.reportPublic FDA data

ZSAlign Cervical Interbody System-Spacer-Wedge

Primary DI
00810216324247
Brand
ZSAlign Cervical Interbody System-Spacer-Wedge
Company
Zsfab, Inc.
Model
ZSAC14160607-M
Catalog number
ZSAC14160607-M
Device description
ZSAlign-C Spacer, Wedge, 14Dx16Wx06Hx07°-M
Published
2026-08-14
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
00810216324247PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810216324247008102163242478102163242470810216324247

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
00810216329235ZSAlign Cervical Interbody System-ScrewZSAC0635014ZSAC06350142026-10-14
00810216329242ZSAlign Cervical Interbody System-ScrewZSAC0635016ZSAC06350162026-10-14
00810216329259ZSAlign Cervical Interbody System-ScrewZSAC0635018ZSAC06350182026-10-14
00810216329266ZSAlign Cervical Interbody System-ScrewZSAC0635020ZSAC06350202026-10-14
00810216329273ZSAlign Cervical Interbody System-ScrewZSAC0640012ZSAC06400122026-10-14
00810216329280ZSAlign Cervical Interbody System-ScrewZSAC0640014ZSAC06400142026-10-14
00810216329297ZSAlign Cervical Interbody System-ScrewZSAC0640016ZSAC06400162026-10-14
00810216329303ZSAlign Cervical Interbody System-ScrewZSAC0640018ZSAC06400182026-10-14
00810216329310ZSAlign Cervical Interbody System-ScrewZSAC0640020ZSAC06400202026-10-14
00810216329334ZSAlign Cervical Interbody System-ScrewZSAC0735014ZSAC07350142026-10-14
00810216329341ZSAlign Cervical Interbody System-ScrewZSAC0735016ZSAC07350162026-10-14
00810216329358ZSAlign Cervical Interbody System-ScrewZSAC0735018ZSAC07350182026-10-14
00810216329372ZSAlign Cervical Interbody System-ScrewZSAC0740012ZSAC07400122026-10-14
00810216329389ZSAlign Cervical Interbody System-ScrewZSAC0740014ZSAC07400142026-10-14
00810216329396ZSAlign Cervical Interbody System-ScrewZSAC0740016ZSAC07400162026-10-14
00810216329402ZSAlign Cervical Interbody System-ScrewZSAC0740018ZSAC07400182026-10-14
00810216329419ZSAlign Cervical Interbody System-ScrewZSAC0740020ZSAC07400202026-10-14
00810236520001ZSFab Lumbar Interbody SystemLPT20100810NR2026-10-10
00810236520018ZSFab Lumbar Interbody SystemLPT20110810NR2026-10-10
00810236520025ZSFab Lumbar Interbody SystemLPT20101015NR2026-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810216329235ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329242ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329259ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329266ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329273ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329280ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329297ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329303ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329310ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329334ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329341ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329358ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329372ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329389ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329396ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329402ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329419ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00889981124390Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981124406Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981124413Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981124420Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981124437Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981124444Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981124451Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981124468Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981142301Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981142318Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981142325Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981142332Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981142349Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26