FDA.reportPublic FDA data

Squadron Lumbar Cage

Primary DI
00811771039065
Brand
Squadron Lumbar Cage
Company
VALORUS SPINE LLC
Model
31-91-003
Device description
Straight Pusher
Published
2023-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171914000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171914000Cortina™ Lumbar Cage SystemNeurostructures, Inc.2017-10-25MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811771039065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811771039065008117710390658117710390650811771039065

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
760-799-4353lfero@valorusspine.com

Regulatory Flags#

DUNS number
080841846
Device count
1
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811771030000Liberty Anterior Cervical Plate20-01-01102023-07-14
00811771030017Liberty Anterior Cervical Plate20-01-01122023-07-14
00811771030024Liberty Anterior Cervical Plate20-01-01142023-07-14
00811771030031Liberty Anterior Cervical Plate20-01-01162023-07-14
00811771030048Liberty Anterior Cervical Plate20-01-01182023-07-14
00811771030055Liberty Anterior Cervical Plate20-01-01202023-07-14
00811771030062Liberty Anterior Cervical Plate20-01-01222023-07-14
00811771030079Liberty Anterior Cervical Plate20-01-01242023-07-14
00811771030086Liberty Anterior Cervical Plate20-01-01262023-07-14
00811771030093Liberty Anterior Cervical Plate20-01-02242023-07-14
00811771030109Liberty Anterior Cervical Plate20-01-02262023-07-14
00811771030116Liberty Anterior Cervical Plate20-01-02282023-07-14
00811771030123Liberty Anterior Cervical Plate20-01-02302023-07-14
00811771030130Liberty Anterior Cervical Plate20-01-02322023-07-14
00811771030147Liberty Anterior Cervical Plate20-01-02342023-07-14
00811771030154Liberty Anterior Cervical Plate20-01-02372023-07-14
00811771030161Liberty Anterior Cervical Plate20-01-02402023-07-14
00811771030178Liberty Anterior Cervical Plate20-01-02432023-07-14
00811771030185Liberty Anterior Cervical Plate20-01-02462023-07-14
00811771030192Liberty Anterior Cervical Plate20-01-03392023-07-14

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Primary DI, Brand, Company table
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00888867550339Arthrex®ARTHREX, INC.LXH2026-09-18
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00888867550353Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550360Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550377Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550384Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552692Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552708Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552715Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552722Arthrex®ARTHREX, INC.LXH2026-09-18
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00888867552746Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552753Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552760Arthrex®ARTHREX, INC.LXH2026-09-18
00888867574564Arthrex®ARTHREX, INC.LXH2026-09-18
00888867574571Arthrex®ARTHREX, INC.LXH2026-09-18
00888867574588Arthrex®ARTHREX, INC.LXH2026-09-18
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04054896000893(Re-) Positioning ToolsSilony Medical GmbHLXH2026-09-18
04054896000909(Re-) Positioning ToolsSilony Medical GmbHLXH2026-09-18
04054896000916(Re-) Positioning ToolsSilony Medical GmbHLXH2026-09-18
04054896000923AdapterSilony Medical GmbHLXH2026-09-18