FDA.reportPublic FDA data

Zavation

Primary DI
00842166180789
Brand
Zavation
Company
Zavation LLC
Model
290-1014
Device description
Removal Drill
Published
2018-05-11
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
MRWSystem, Facet Screw Spinal Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRWSystem, Facet Screw Spinal DeviceUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132126000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132126000SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEMSpectrum Spine, LLC2013-10-28MRW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842166180789PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842166180789008421661807898421661807890842166180789

GMDN Terms#

Term, Definition table
TermDefinition
Trans-facet-screw internal spinal fixation system, non-sterileA non-sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions. This is a single-use device intended to be sterilized prior to use.

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
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
00888867614543Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614550Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614567Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614574Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614581Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614598Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614604Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614611Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614628Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614635Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614642Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614659Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614666Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614673Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614680Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614697Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614703Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614710Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614727Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614734Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614741Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614758Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614765Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614772Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614789Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614796Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614802Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614819Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614826Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614833Arthrex®ARTHREX, INC.MRW2026-10-07