FDA.reportPublic FDA data

Zero-P

Primary DI
10705034716749
Brand
Zero-P
Company
Synthes GmbH
Model
03.617.730
Catalog number
03617730
Device description
ZERO-P TRIAL SPACER/PARALLEL LARGE/10MM HEIGHT
Published
2015-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K112459000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112459000SYNTHES ZERO-PSynthes Spine Co.Lp2011-12-12OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819389687Direct MarkingGS10
10705034716749PrimaryGS10
H981036177300SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819389687076118193896877611819389687
1070503471674910705034716749

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982239297NA519.51519512017-02-20
10886982195937NA357.2223572222017-02-20
10886982238115NA511.9045119042016-12-31
10886982239358NA519.53519532016-12-31
10886982249043NA60.550.011605500112017-02-20
10886982249104NA60.550.016605500162017-02-20
10886982249135NA60.550.020605500202017-02-20
10886982249142NA60.550.021605500212017-02-20
10886982254917NA690.5946905942017-02-20
10886982362797NASD03.111.915SD031119152026-08-26
10886982362803NASD03.111.916SD031119162026-08-26
10886982362810NASD03.111.917SD031119172026-08-26
10886982362827NASD03.111.918SD031119182026-08-26
10886982362834NASD03.111.919SD031119192026-08-26
10886982362988NASD312.030SD3120302026-08-26
10886982362995NASD312.031SD3120312026-08-26
10886982363008NASD312.032SD3120322026-08-26
10886982363015NASD312.033SD3120332026-08-26
10887587078496NASD03.503.037SD035030372026-08-26
10887587078595NASD03.501.444SD035014442026-08-26

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