FDA.reportPublic FDA data

ZAVATION

Primary DI
00842166189911
Brand
ZAVATION
Company
Zavation LLC
Model
599-1002-L
Device description
Inserter Occipital Plate
Published
2022-03-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal
NKGPosterior Cervical Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
NKGPosterior Cervical Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211993000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211993000Z-LINKPC SystemZavation Medical Products, LLC2021-08-11NKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842166189911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842166189911008421661899118421661899110842166189911

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and 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). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

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
00197157119089ZAVATION SCREW1011-O-095055-F-S2026-10-05
00197157119096ZAVATION SCREW1011-O-095060-F-S2026-10-05
00197157119102ZAVATION SCREW1011-O-095065-F-S2026-10-05
00197157119119ZAVATION SCREW1011-O-095070-F-S2026-10-05
00197157119126ZAVATION SCREW1011-O-095075-F-S2026-10-05
00197157119133ZAVATION SCREW1011-O-095080-F-S2026-10-05
00197157119140ZAVATION SCREW1011-O-095085-F-S2026-10-05
00197157119157ZAVATION SCREW1011-O-095090-F-S2026-10-05
00197157119164ZAVATION SCREW1011-O-095095-F-S2026-10-05
00197157119171ZAVATION SCREW1011-O-095100-F-S2026-10-05
00197157119188ZAVATION SCREW1011-O-095105-F-S2026-10-05
00197157119195ZAVATION SCREW1011-O-095110-F-S2026-10-05
00197157119201ZAVATION SCREW1011-O-105025-S-C2026-10-05
00197157119218ZAVATION SCREW1011-O-105030-S-C2026-10-05
00197157119225ZAVATION SCREW1011-O-105035-S-C2026-10-05
00197157119232ZAVATION SCREW1011-O-105040-S-C2026-10-05
00197157119249ZAVATION SCREW1011-O-105045-S-C2026-10-05
00197157119256ZAVATION SCREW1011-O-105050-S-C2026-10-05
00197157119263ZAVATION SCREW1011-O-105055-S-C2026-10-05
00197157119270ZAVATION SCREW1011-O-105060-S-C2026-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800322693100VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693117VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693124VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693131VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693148VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693155VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693162VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
10888857598256Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598263Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598270Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598287Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598294Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598300Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598317Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598324Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598331Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598348Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598355Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598362Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598379Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598386Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598393Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598409Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598416Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598423Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598430Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598447Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598454Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598461Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598478Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24