FDA.reportPublic FDA data

Zavation Sizer

Primary DI
00197157027070
Brand
Zavation Sizer
Company
Zavation LLC
Model
23-2000-10
Device description
Sizer, 0 deg, 7 & 8 mm
Published
2024-09-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162206000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162206000Zavation IBFZavation, LLC2017-04-04MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197157027070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157027070001971570270701971570270700197157027070

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant/trial-implant/sizer holder, reusableA hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
6019191119info@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
00197157059521ZAVATION RODR5522-0852026-06-04
00197157059538ZAVATION RODR5522-0902026-06-04
00197157059545ZAVATION RODR5522-0952026-06-04
00197157059552ZAVATION RODR5522-1002026-06-04
00197157059569ZAVATION RODR5522-1052026-06-04
00197157059576ZAVATION RODR5522-1102026-06-04
00197157059583ZAVATION RODR5522-1152026-06-04
00197157059590ZAVATION RODR5522-1202026-06-04
00197157059606ZAVATION RODR5522-1252026-06-04
00197157059613ZAVATION RODR5522-1302026-06-04
00197157059620ZAVATION RODR5522-1352026-06-04
00197157059637ZAVATION RODR5522-1402026-06-04
00197157059644ZAVATION RODR5522-1452026-06-04
00197157059651ZAVATION RODR5522-1502026-06-04
00197157059668ZAVATION RODR5522-1602026-06-04
00197157081515ZAVATION SCREW35035-102026-06-04
00197157081522ZAVATION SCREW35035-122026-06-04
00197157081539ZAVATION SCREW35035-142026-06-04
00197157081546ZAVATION SCREW35035-162026-06-04
00197157081553ZAVATION SCREW35035-182026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809986491145CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491152CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491169CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491176CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491183CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491190CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491206CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491213CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491220CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491237CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491244CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491251CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491268CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491275CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491282CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491299CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491305CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491312CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491329CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491336CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491343CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491350CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491367CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491374CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491381CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491398CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
00840311248360Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-03
00840311248421Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-03
00840311248438Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-03
00840311248445Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-03