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
00197157118280ZAVATION SCREW1011-O-095105-S-C2026-10-01
00197157118297ZAVATION SCREW1011-O-095110-S-C2026-10-01
00197157118303ZAVATION SCREW1011-O-095025-S-S2026-10-01
00197157118310ZAVATION SCREW1011-O-095030-S-S2026-10-01
00197157118327ZAVATION SCREW1011-O-095035-S-S2026-10-01
00197157118334ZAVATION SCREW1011-O-095040-S-S2026-10-01
00197157118341ZAVATION SCREW1011-O-095045-S-S2026-10-01
00197157118358ZAVATION SCREW1011-O-095050-S-S2026-10-01
00197157118365ZAVATION SCREW1011-O-095055-S-S2026-10-01
00197157118372ZAVATION SCREW1011-O-095060-S-S2026-10-01
00197157118389ZAVATION SCREW1011-O-095065-S-S2026-10-01
00197157118396ZAVATION SCREW1011-O-095070-S-S2026-10-01
00197157118402ZAVATION SCREW1011-O-095075-S-S2026-10-01
00197157118419ZAVATION SCREW1011-O-095080-S-S2026-10-01
00197157118426ZAVATION SCREW1011-O-095085-S-S2026-10-01
00197157118433ZAVATION SCREW1011-O-095090-S-S2026-10-01
00197157118440ZAVATION SCREW1011-O-095095-S-S2026-10-01
00197157118457ZAVATION SCREW1011-O-095100-S-S2026-10-01
00197157118464ZAVATION SCREW1011-O-095105-S-S2026-10-01
00197157118471ZAVATION SCREW1011-O-095110-S-S2026-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017916214SABER-XA, Anterior Plate, 37Wx13HELEVATION SPINE, INC.OVE2026-10-01
00810204090017Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090024Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090031Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090048Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090055Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090062Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090079Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090086Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090093Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090109Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090116Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090123Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090130Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090147Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090154Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090161Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090178Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090185Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090192Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810017916108SABER-XA, Expandable Spacer, 34x26mm, 11mm, (6°)ELEVATION SPINE, INC.OVE2026-09-29
00810017916115SABER-XA, Expandable Spacer, 34x26mm, 13mm, (12°)ELEVATION SPINE, INC.OVE2026-09-29
00810017916122SABER-XA, Expandable Spacer, 34x26mm, 16mm, (18°)ELEVATION SPINE, INC.OVE2026-09-29
00810017916177SABER-XA, Expandable Spacer, 37x28mm,11mm, (6°)ELEVATION SPINE, INC.OVE2026-09-29
00810017915125SABER-XA, Screw Ø5.0 x 22.5ELEVATION SPINE, INC.OVE2026-09-22
00810017915149SABER-XA, Screw Ø5.0 x 32.5ELEVATION SPINE, INC.OVE2026-09-22
00810017915156SABER-XA, Screw Ø5.5 x 22.5ELEVATION SPINE, INC.OVE2026-09-22
00810017915163SABER-XA, Screw Ø5.5 x 27.5ELEVATION SPINE, INC.OVE2026-09-22
10888857026551CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2022-06-06
10888857026582CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2022-06-06