FDA.reportPublic FDA data

ZAVATION TAP

Primary DI
00197157068486
Brand
ZAVATION TAP
Company
Zavation LLC
Model
ZAV-1381-40
Device description
TAP POSTERIOR CERVICAL
Published
2026-05-20
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
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181244000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181244000Zavation Cervical Plate SystemZavation Medical Products, LLC2018-07-10KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197157068486PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157068486001971570684861971570684860197157068486

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA surgical instrument designed for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). The screws may be used to anchor bone fragments, fixtures and/or other devices to the bone. It is typically manually rotated and consists of a metal shaft with a helical thread which may be cannulated or intersected with longitudinal cutting grooves. 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
00197157068332ZAVATION INSTRUMENT TRAY14T009142026-05-20
00197157068349ZAVATION INSTRUMENT TRAY14T009152026-05-20
00197157068356ZAVATION INSTRUMENT TRAY14T009162026-05-20
00197157068363ZAVATION INSTRUMENT TRAY14T009172026-05-20
00197157068370ZAVATION INSTRUMENT TRAY14T009192026-05-20
00197157068387ZAVATION INSTRUMENT TRAY14T009202026-05-20
00197157068394ZAVATION INSTRUMENT TRAY14T009212026-05-20
00197157068400ZAVATION INSTRUMENT TRAY14T009222026-05-20
00197157068417ZAVATION INSTRUMENT TRAY14T009242026-05-20
00197157068424ZAVATION INSTRUMENT TRAY14T009252026-05-20
00197157068431ZAVATION INSTRUMENT TRAY14T009262026-05-20
00197157068448ZAVATION INSTRUMENT TRAY14T009272026-05-20
00197157068455ZAVATION INSTRUMENT TRAY14T009282026-05-20
00197157068462ZAVATION TAPZAV-1381-302026-05-20
00197157068479ZAVATION TAPZAV-1381-352026-05-20
00197157068493ZAVATION INSTRUMENT989-2032-42026-05-20
00197157073138ZAVATION INSTRUMENT TRAY14L004642026-05-20
00197157073145ZAVATION INSTRUMENT TRAY14L004662026-05-20
00197157067052ZAVATION K-WIRE989-2072-12026-05-19
00197157067069ZAVATION K-WIRE989-2072-22026-05-19

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Primary DI, Brand, Company table
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07640332477991SCARLET® AC-TiSpineArt SAODP2024-08-05
07640332478004SCARLET® AC-TiSpineArt SAODP2024-08-05
07640332478011SCARLET® AC-TiSpineArt SAODP2024-08-05
07640332477984SCARLET® AC-TiSpineArt SAODP2024-08-02
07640332478684SCARLET® AC-TiSpineArt SAODP2024-08-02
07640332478691SCARLET® AC-TiSpineArt SAODP2024-08-02
07640332478707SCARLET® AC-TiSpineArt SAODP2024-08-02
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07640332478721SCARLET® AC-TiSpineArt SAODP2024-08-02
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07640185341760SCARLET® AC-T Secured Anterior Cervical CageSpineArt SAODP2019-03-08
07640185341784SCARLET® AC-T Secured Anterior Cervical CageSpineArt SAODP2019-03-08
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07640140433783icotec Cervical Cage, Cervical Cage Anatomic, Container, completeicotec AGODP2018-07-16
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