FDA.reportPublic FDA data

Zavation

Primary DI
00842166105799
Brand
Zavation
Company
Zavation LLC
Model
32-4016
Device description
Self Drilling Fixed Screw, 4.0mmx16
Published
2016-11-08
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
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842166105799PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842166105799008421661057998421661057990842166105799

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, sterile, threaded rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold plates, or other stabilization device, to bone; it 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 available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

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
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
00197157068486ZAVATION TAPZAV-1381-402026-05-20
00197157068493ZAVATION INSTRUMENT989-2032-42026-05-20
00197157073138ZAVATION INSTRUMENT TRAY14L004642026-05-20
00197157073145ZAVATION INSTRUMENT TRAY14L004662026-05-20
00197157067052ZAVATION K-WIRE989-2072-12026-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613153045731XIA IStryker CorporationKWQ2014-12-08
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07613153045755XIA IStryker CorporationKWQ2014-12-08
07613153045762XIA IIStryker CorporationKWQ2014-12-08
07613153045793XIA IIStryker CorporationKWQ2014-12-08
07613153045854XIA IIStryker CorporationKWQ2014-12-08
07613153045878XIA IIStryker CorporationKWQ2014-12-08
07613153045885XIA IIStryker CorporationKWQ2014-12-08
07613153045892XIA IIStryker CorporationKWQ2014-12-08
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07613153045915XIA IIStryker CorporationKWQ2014-12-08
07613153045922XIA IIStryker CorporationKWQ2014-12-08
07613153045939XIA IIStryker CorporationKWQ2014-12-08
07613153045960XIA IIStryker CorporationKWQ2014-12-08
07613153046011XIA STAINLESS STEELStryker CorporationKWQ2014-12-08
07613153046028XIA STAINLESS STEELStryker CorporationKWQ2014-12-08
07613153046035XIA STAINLESS STEELStryker CorporationKWQ2014-12-08
07613153046042XIA STAINLESS STEELStryker CorporationKWQ2014-12-08
07613153046059XIA STAINLESS STEELStryker CorporationKWQ2014-12-08
07613153046066XIA STAINLESS STEELStryker CorporationKWQ2014-12-08
07613153046073XIA STAINLESS STEELStryker CorporationKWQ2014-12-08
07613153046103XIA STAINLESS STEELStryker CorporationKWQ2014-12-08
07613153046110XIA STAINLESS STEELStryker CorporationKWQ2014-12-08
07613153046127XIA STAINLESS STEELStryker CorporationKWQ2014-12-08
07613153046134XIA STAINLESS STEELStryker CorporationKWQ2014-12-08