FDA.reportPublic FDA data

ZSAlign Cervical Interbody System-Screw

Primary DI
00810216329235
Brand
ZSAlign Cervical Interbody System-Screw
Company
Zsfab, Inc.
Model
ZSAC0635014
Catalog number
ZSAC0635014
Device description
ZSAlign-C Screw, VA Self-Drilling, Enhanced,3.5*14
Published
2026-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810216329235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810216329235008102163292358102163292350810216329235

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00810236520032ZSFab Lumbar Interbody SystemLPT20111015NR2026-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00889981142356Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26