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

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system connectorAn implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.

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
00197157118280ZAVATION SCREW1011-O-095105-S-C2026-10-01
00197157118297ZAVATION SCREW1011-O-095110-S-C2026-10-01
00197157118303ZAVATION SCREW1011-O-095025-S-S2026-10-01
00197157118310ZAVATION SCREW1011-O-095030-S-S2026-10-01
00197157118327ZAVATION SCREW1011-O-095035-S-S2026-10-01
00197157118334ZAVATION SCREW1011-O-095040-S-S2026-10-01
00197157118341ZAVATION SCREW1011-O-095045-S-S2026-10-01
00197157118358ZAVATION SCREW1011-O-095050-S-S2026-10-01
00197157118365ZAVATION SCREW1011-O-095055-S-S2026-10-01
00197157118372ZAVATION SCREW1011-O-095060-S-S2026-10-01
00197157118389ZAVATION SCREW1011-O-095065-S-S2026-10-01
00197157118396ZAVATION SCREW1011-O-095070-S-S2026-10-01
00197157118402ZAVATION SCREW1011-O-095075-S-S2026-10-01
00197157118419ZAVATION SCREW1011-O-095080-S-S2026-10-01
00197157118426ZAVATION SCREW1011-O-095085-S-S2026-10-01
00197157118433ZAVATION SCREW1011-O-095090-S-S2026-10-01
00197157118440ZAVATION SCREW1011-O-095095-S-S2026-10-01
00197157118457ZAVATION SCREW1011-O-095100-S-S2026-10-01
00197157118464ZAVATION SCREW1011-O-095105-S-S2026-10-01
00197157118471ZAVATION SCREW1011-O-095110-S-S2026-10-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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