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
00197157117214ZAVATION SCREW1011-O-085110-S-C2026-09-21
00197157117221ZAVATION SCREW1011-O-085025-S-S2026-09-21
00197157117238ZAVATION SCREW1011-O-085030-S-S2026-09-21
00197157117245ZAVATION SCREW1011-O-085035-S-S2026-09-21
00197157117252ZAVATION SCREW1011-O-085040-S-S2026-09-21
00197157117269ZAVATION SCREW1011-O-085045-S-S2026-09-21
00197157117276ZAVATION SCREW1011-O-085050-S-S2026-09-21
00197157117283ZAVATION SCREW1011-O-085055-S-S2026-09-21
00197157117290ZAVATION SCREW1011-O-085060-S-S2026-09-21
00197157117306ZAVATION SCREW1011-O-085065-S-S2026-09-21
00197157117313ZAVATION SCREW1011-O-085070-S-S2026-09-21
00197157117320ZAVATION SCREW1011-O-085075-S-S2026-09-21
00197157117337ZAVATION SCREW1011-O-085080-S-S2026-09-21
00197157117344ZAVATION SCREW1011-O-085085-S-S2026-09-21
00197157117351ZAVATION SCREW1011-O-085090-S-S2026-09-21
00197157117368ZAVATION SCREW1011-O-085095-S-S2026-09-21
00197157117375ZAVATION SCREW1011-O-085100-S-S2026-09-21
00197157117382ZAVATION SCREW1011-O-085105-S-S2026-09-21
00197157117399ZAVATION SCREW1011-O-085110-S-S2026-09-21
00197157117405ZAVATION SCREW1011-O-085025-C-C2026-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017915125SABER-XA, Screw Ø5.0 x 22.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915149SABER-XA, Screw Ø5.0 x 32.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915156SABER-XA, Screw Ø5.5 x 22.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915163SABER-XA, Screw Ø5.5 x 27.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915170SABER-XA, Screw Ø5.5 x 32.5ELEVATION SPINE, INC.KWQ2026-09-22
10888857598164Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598171Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598188Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598195Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598201Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598218Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598225Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598232Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598249Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
00810056993146corraCarlsmed, Inc.KWQ2026-01-30
00613994568311TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2015-08-05
00613994568823TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2015-08-05
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