FDA.reportPublic FDA data

ZSAlign Cervical Interbody System-Plate

Primary DI
00810216328610
Brand
ZSAlign Cervical Interbody System-Plate
Company
Zsfab, Inc.
Model
ZSAC0102006
Catalog number
ZSAC0102006
Device description
ZSAlign-C Plate,2 hole,6
Published
2026-08-14
Public version status
Update
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
00810216328610PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810216328610008102163286108102163286100810216328610

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization as part of treatment of a spinal instability or deformity; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.

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
00810216325312ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16160610-LZSAC16160610-L2026-08-13
00810216325329ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16160610-MZSAC16160610-M2026-08-13
00810216325336ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16160610-HZSAC16160610-H2026-08-13
00810216325343ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16160710-LZSAC16160710-L2026-08-13
00810216325350ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16160710-MZSAC16160710-M2026-08-13
00810216325367ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16160710-HZSAC16160710-H2026-08-13
00810216325374ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16160810-LZSAC16160810-L2026-08-13
00810216325381ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16160810-MZSAC16160810-M2026-08-13
00810216325404ZSAlign Cervical Interbody System-Spacer-WedgevZSAC16160910-LZSAC16160910-L2026-08-13
00810216325411ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16160910-MZSAC16160910-M2026-08-13
00810216325428ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16160910-HZSAC16160910-H2026-08-13
00810216325435ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16161010-LZSAC16161010-L2026-08-13
00810216325459ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16161010-HZSAC16161010-H2026-08-13
00810216325473ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16161110-MZSAC16161110-M2026-08-13
00810216325480ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16161110-HZSAC16161110-H2026-08-13
00810216325497ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16161210-LZSAC16161210-L2026-08-13
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

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
00810216325954ZSAlign 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