FDA.reportPublic FDA data

Zavation

Primary DI
00197157005276
Brand
Zavation
Company
Zavation LLC
Model
540-1013
Device description
Steinmann Pin
Published
2024-01-10
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197157005276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157005276001971570052761971570052760197157005276

GMDN Terms#

Term, Definition table
TermDefinition
Sacroiliac joint transarticular fixation/arthrodesis implantation kitA collection of surgical instruments and devices intended to be used for the implantation of a sacroiliac joint transarticular fixation/arthrodesis implant during a minimally-invasive procedure. It typically consists of a tray, dedicated soft-tissue protectors, depth gauges, pin sleeves, drill sleeves, drill bits, broaches, a parallel pin guide, handles, slide hammer shafts, impactors, and a removal/adaptor tool; the implant(s) is not included. This is a reusable device.

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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197157075835ZAVATION DRIVERZAV-13982026-05-27
00197157075842ZAVATION K-WIREZAV-13972026-05-27
00197157075859ZAVATION INSERTERZAV-10552026-05-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810166522816Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522823Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522830Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522847Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522854Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522861Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522878Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00889929072424Matrixx SystemNEXXT SPINE, LLCLXH2026-05-27
07640187918809Straight reamer handleMPS Micro Precision Systems AGLXH2026-05-27
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07613327142662XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-25
07613327142679XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-25
07613327177480OASYSStryker CorporationLXH2019-11-25
07613327261752DIAPASONStryker CorporationLXH2019-11-25
07613327261943O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327261950O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327261967O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327261974O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327261998O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262001O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262018O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262025O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262032O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262049O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262056O.I.C. TITANIUMStryker CorporationLXH2019-11-25