FDA.reportPublic FDA data

ZAVATION ROD CONNECTOR

Primary DI
00197157016296
Brand
ZAVATION ROD CONNECTOR
Company
Zavation LLC
Model
880-1111-14
Device description
ROD CONNECTOR, PARALLEL CLOSED 14mm OFFSET, Ø 3.5 X 3.5mm
Published
2025-06-04
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
00197157016296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157016296001971570162961971570162960197157016296

GMDN Terms#

Term, Definition table
TermDefinition
Radiological chest positionerA device intended to facilitate adequate positioning and immobilization of the patient's chest/thoracic area during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. The device is in the form of a frame, board, cushion, or preformed pad that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.

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
00197157082130ZAVATION SCREW35045-502026-07-23
00197157082147ZAVATION SCREW35740-102026-07-23
00197157082154ZAVATION SCREW35740-122026-07-23
00197157082161ZAVATION SCREW35740-142026-07-23
00197157082178ZAVATION SCREW35740-162026-07-23
00197157082185ZAVATION SCREW35740-182026-07-23
00197157082192ZAVATION SCREW35740-202026-07-23
00197157082208ZAVATION SCREW35740-222026-07-23
00197157082215ZAVATION SCREW35740-242026-07-23
00197157082222ZAVATION SCREW35740-262026-07-23
00197157082239ZAVATION SCREW35740-282026-07-23
00197157082246ZAVATION SCREW35740-302026-07-23
00197157082253ZAVATION SCREW35740-322026-07-23
00197157082260ZAVATION SCREW35740-342026-07-23
00197157082277ZAVATION SCREW35740-362026-07-23
00197157082284ZAVATION SCREW35740-382026-07-23
00197157082291ZAVATION SCREW35740-402026-07-23
00197157082307ZAVATION SCREW35740-422026-07-23
00197157082314ZAVATION SCREW35740-442026-07-23
00197157082321ZAVATION SCREW35740-462026-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840493425566RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425573RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425580RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425597RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425603RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425610RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425627RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425634RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425641RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425658RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425665RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425672RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425689RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425696RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425702RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425719RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425726RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00763000992026MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-08-02
00763000887216MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-07-30
00840493425382RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425399RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425405RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425412RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425429RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425436RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425443RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425450RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425467RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425474RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28