FDA.reportPublic FDA data

ZAVATION ROD CADDY

Primary DI
00197157073046
Brand
ZAVATION ROD CADDY
Company
Zavation LLC
Model
989-9002-13
Device description
TIGER 2 6.0 PRE BENT ROD CADDY
Published
2025-09-16
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
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180673000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180673000Normandy VBR SystemZavation Medical Products, LLC2018-07-13PLR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197157073046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157073046001971570730461971570730460197157073046

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. 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
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
00197157123017ZAVATION SCREW1010-C-065040-C-S2026-10-20
00197157123024ZAVATION SCREW1010-C-065045-C-S2026-10-20
00197157123031ZAVATION SCREW1010-C-065050-C-S2026-10-20
00197157123048ZAVATION SCREW1010-C-065055-C-S2026-10-20
00197157123055ZAVATION SCREW1010-C-065060-C-S2026-10-20
00197157123062ZAVATION SCREW1010-C-065065-C-S2026-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157122874ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122881ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122898ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122904ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122911ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122928ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122935ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122942ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122959ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122966ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122973ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122980ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122997ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123000ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123017ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123024ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123031ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123048ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123055ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123062ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123079ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123086ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123093ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123109ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123116ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123123ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123130ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123147ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123154ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123161ZAVATION SCREWZavation LLCNKB2026-10-20