FDA.reportPublic FDA data

ZAVATION ROD CONNECTOR

Primary DI
00197157017217
Brand
ZAVATION ROD CONNECTOR
Company
Zavation LLC
Model
880-60-0103
Device description
ROD CONNECTOR, U-ROD LEFT Ø 5.5 ROD, 5.5/6.0mm
Published
2025-06-05
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
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222614000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222614000Zavation Spinal SystemZavation Medical Products, LLC2022-12-05NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197157017217PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157017217001971570172171971570172170197157017217

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
00197157125325ZAVATION SCREW1010-C-085060-F-C2026-11-05
00197157125332ZAVATION SCREW1010-C-085065-F-C2026-11-05
00197157125349ZAVATION SCREW1010-C-085070-F-C2026-11-05
00197157125356ZAVATION SCREW1010-C-085075-F-C2026-11-05
00197157125363ZAVATION SCREW1010-C-085080-F-C2026-11-05
00197157125370ZAVATION SCREW1010-C-085085-F-C2026-11-05
00197157125387ZAVATION SCREW1010-C-085090-F-C2026-11-05
00197157125394ZAVATION SCREW1010-C-085095-F-C2026-11-05
00197157125400ZAVATION SCREW1010-C-085100-F-C2026-11-05
00197157125417ZAVATION SCREW1010-C-085105-F-C2026-11-05
00197157125424ZAVATION SCREW1010-C-085110-F-C2026-11-05
00197157125448ZAVATION SCREW1010-C-085030-F-S2026-11-05
00197157125455ZAVATION SCREW1010-C-085035-F-S2026-11-05
00197157125462ZAVATION SCREW1010-C-085040-F-S2026-11-05
00197157125479ZAVATION SCREW1010-C-085045-F-S2026-11-05
00197157125486ZAVATION SCREW1010-C-085050-F-S2026-11-05
00197157125493ZAVATION SCREW1010-C-085055-F-S2026-11-05
00197157125509ZAVATION SCREW1010-C-085075-F-S2026-11-05
00197157125516ZAVATION SCREW1010-C-085085-F-S2026-11-05
00197157125523ZAVATION SCREW1010-C-085095-F-S2026-11-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841732169371TAURUS LX Pedicle Screw SystemCTL Medical CorporationKWQ2026-11-04
08800322699775AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08800322699782AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08800322699799AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08800424704032AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08800424704049AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08800424704056AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885719654AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885719661AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885719678AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885719685AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885719692AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885799939AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885799946AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885799953AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974809969AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974809976AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974809983AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974809990AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819852AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819869AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819876AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819883AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819890AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819906AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819913AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819920AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819937AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819944AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
B06221006200White Pearl Preferred Angle ACPOsseus Fusion Systems, LLCKWQ2017-10-09