FDA.reportPublic FDA data

Zavation Medical Products, LLC

Primary DI
00842166196872
Brand
Zavation Medical Products, LLC
Company
Zavation LLC
Model
ZAV-1303
Device description
2.5mm K-Wire/Long
Published
2023-12-19
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
HWCScrew, Fixation, Bone
OURSacroiliac Joint Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2
OURSacroiliac Joint FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173752000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173752000SI Screw SystemZavation Medical Products, LLC2018-03-16OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842166196872PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842166196872008421661968728421661968720842166196872

GMDN Terms#

Term, Definition table
TermDefinition
Sacroiliac joint intra-articular arthrodesis implantAn implantable device designed to achieve and maintain the distraction of degenerated articular surfaces of the sacroiliac joint to assist in intra- and extra-articular bone grafting and fusion (arthrodesis), typically performed to alleviate pain from the sacroiliac joints in skeletally mature patients. The device is a tapered tube made of titanium alloy which has radial fenestrations to encourage bony in-growth. It is surgically implanted under fluoroscopic guidance using an assortment of dedicated tools. It is available in several sizes and intended for permanent implantation.

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
00197157119089ZAVATION SCREW1011-O-095055-F-S2026-10-05
00197157119096ZAVATION SCREW1011-O-095060-F-S2026-10-05
00197157119102ZAVATION SCREW1011-O-095065-F-S2026-10-05
00197157119119ZAVATION SCREW1011-O-095070-F-S2026-10-05
00197157119126ZAVATION SCREW1011-O-095075-F-S2026-10-05
00197157119133ZAVATION SCREW1011-O-095080-F-S2026-10-05
00197157119140ZAVATION SCREW1011-O-095085-F-S2026-10-05
00197157119157ZAVATION SCREW1011-O-095090-F-S2026-10-05
00197157119164ZAVATION SCREW1011-O-095095-F-S2026-10-05
00197157119171ZAVATION SCREW1011-O-095100-F-S2026-10-05
00197157119188ZAVATION SCREW1011-O-095105-F-S2026-10-05
00197157119195ZAVATION SCREW1011-O-095110-F-S2026-10-05
00197157119201ZAVATION SCREW1011-O-105025-S-C2026-10-05
00197157119218ZAVATION SCREW1011-O-105030-S-C2026-10-05
00197157119225ZAVATION SCREW1011-O-105035-S-C2026-10-05
00197157119232ZAVATION SCREW1011-O-105040-S-C2026-10-05
00197157119249ZAVATION SCREW1011-O-105045-S-C2026-10-05
00197157119256ZAVATION SCREW1011-O-105050-S-C2026-10-05
00197157119263ZAVATION SCREW1011-O-105055-S-C2026-10-05
00197157119270ZAVATION SCREW1011-O-105060-S-C2026-10-05

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03700569634049NANEWCLIP TECHNICSHWC2026-10-01
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