FDA.reportPublic FDA data

Zavation

Primary DI
00842166183117
Brand
Zavation
Company
Zavation LLC
Model
171-2000-04
Device description
Large Sizer, 0 deg, 12 & 12mm
Published
2021-01-07
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
K141005000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141005000Z-LINK CERVICALZavation, LLC2014-08-07OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842166183117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842166183117008421661831178421661831170842166183117

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric 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 in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] 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 included with the device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
601-919-1119info@zavation.com

Regulatory Flags#

DUNS number
069472800
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197157123611ZAVATION SCREW1010-C-075070-S-C2026-10-21
00197157123628ZAVATION SCREW1010-C-075075-S-C2026-10-21
00197157123635ZAVATION SCREW1010-C-075080-S-C2026-10-21
00197157123642ZAVATION SCREW1010-C-075085-S-C2026-10-21
00197157123659ZAVATION SCREW1010-C-075090-S-C2026-10-21
00197157123666ZAVATION SCREW1010-C-075095-S-C2026-10-21
00197157122874ZAVATION SCREW1010-C-065060-C-C2026-10-20
00197157122881ZAVATION SCREW1010-C-065065-C-C2026-10-20
00197157122898ZAVATION SCREW1010-C-065070-C-C2026-10-20
00197157122904ZAVATION SCREW1010-C-065075-C-C2026-10-20
00197157122911ZAVATION SCREW1010-C-065080-C-C2026-10-20
00197157122928ZAVATION SCREW1010-C-065085-C-C2026-10-20
00197157122935ZAVATION SCREW1010-C-065090-C-C2026-10-20
00197157122942ZAVATION SCREW1010-C-065095-C-C2026-10-20
00197157122959ZAVATION SCREW1010-C-065100-C-C2026-10-20
00197157122966ZAVATION SCREW1010-C-065105-C-C2026-10-20
00197157122973ZAVATION SCREW1010-C-065110-C-C2026-10-20
00197157122980ZAVATION SCREW1010-C-065025-C-S2026-10-20
00197157122997ZAVATION SCREW1010-C-065030-C-S2026-10-20
00197157123000ZAVATION SCREW1010-C-065035-C-S2026-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017913763Saber-C Body (PT), 14x15x5 6 deg.ELEVATION SPINE, INC.OVE2026-10-26
00810017913770Saber-C Body (PT), 14x15x6 6 deg.ELEVATION SPINE, INC.OVE2026-10-26
00810017913787Saber-C Body (PT), 14x15x7 6 deg.ELEVATION SPINE, INC.OVE2026-10-26
00810017913794Saber-C Body (PT), 14x15x8 6 deg.ELEVATION SPINE, INC.OVE2026-10-26
00810017913800Saber-C Body (PT), 14x15x9 6 deg.ELEVATION SPINE, INC.OVE2026-10-26
00810017913817Saber-C Body (PT), 14x15x10 6 deg.ELEVATION SPINE, INC.OVE2026-10-26
00810017913824Saber-C Body (PT), 14x15x5 9 deg.ELEVATION SPINE, INC.OVE2026-10-26
00810017913930Saber-C Body (PT), 14x17x10 6 deg.ELEVATION SPINE, INC.OVE2026-10-26
00810017913947Saber-C Body (PT), 14x17x5 9 deg.ELEVATION SPINE, INC.OVE2026-10-26
00810017913954Saber-C Body (PT), 14x17x6 9 deg.ELEVATION SPINE, INC.OVE2026-10-26
00810017913961Saber-C Body (PT), 14x17x7 9 deg.ELEVATION SPINE, INC.OVE2026-10-26
00810017913978Saber-C Body (PT), 14x17x8 9 deg.ELEVATION SPINE, INC.OVE2026-10-26
00810017913985Saber-C Body (PT), 14x17x9 9 deg.ELEVATION SPINE, INC.OVE2026-10-26
00810017913992Saber-C Body (PT), 14x17x10 9 deg.ELEVATION SPINE, INC.OVE2026-10-26
00810017914005Saber-C Body (PT), 15x18x5 6 deg.ELEVATION SPINE, INC.OVE2026-10-26
00810017914012Saber-C Body (PT), 15x18x6 6 deg.ELEVATION SPINE, INC.OVE2026-10-26
00810017914029Saber-C Body (PT), 15x18x7 6 deg.ELEVATION SPINE, INC.OVE2026-10-26
00810017914036Saber-C Body (PT), 15x18x8 6 deg.ELEVATION SPINE, INC.OVE2026-10-26
00810017914043Saber-C Body (PT), 15x18x9 6 deg.ELEVATION SPINE, INC.OVE2026-10-26
00810017914050Saber-C Body (PT), 15x18x10 6 deg.ELEVATION SPINE, INC.OVE2026-10-26
00810017914425Saber-C Body (PT), 14x15x6 12 deg.ELEVATION SPINE, INC.OVE2026-10-26
00810017914432Saber-C Body (PT), 14x15x7 12 deg.ELEVATION SPINE, INC.OVE2026-10-26
00810017914449Saber-C Body (PT), 14x15x8 12 deg.ELEVATION SPINE, INC.OVE2026-10-26
00810017914456Saber-C Body (PT), 14x15x9 12 deg.ELEVATION SPINE, INC.OVE2026-10-26
00810017914463Saber-C Body (PT), 14x15x10 12 deg.ELEVATION SPINE, INC.OVE2026-10-26
00810017914654Saber-C Body (PT), 15x18x5 12 deg.ELEVATION SPINE, INC.OVE2026-10-26
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