FDA.reportPublic FDA data

Squadron Lumbar Cage

Primary DI
00811771038860
Brand
Squadron Lumbar Cage
Company
VALORUS SPINE LLC
Model
31-91-006-03-280909
Device description
28mm X 09mm X 09mm Anatomic Trials with Handle
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
00811771038860PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811771038860008117710388608117710388600811771038860

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant/trial-implant/sizer holder, reusableA hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809986489753LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-08
08809986489760LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-08
08809986489777LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-08
08809986489784LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-08
08809986489791LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-08
00190776433666MillenniumAvalign Technologies, Inc.LXH2026-10-07
00810017915972T-Handle, 1/4" Sq, RatchetingELEVATION SPINE, INC.LXH2026-10-07
00810017915996Torque Limiting Expansion Driver Handle, 3.0NmELEVATION SPINE, INC.LXH2026-10-07
00810055525751Onyx Dual End Set Screw StarterSi-Bone Inc.LXH2026-10-06
B7685216080Buxton Biomedical, IncBUXTON BIOMEDICAL, INC.LXH2026-10-06
00810228161731corraCarlsmed, Inc.LXH2026-10-05
00840493441641LUX Expandable Interbody SystemXENIX MEDICAL LLCLXH2026-10-05
00840493441658LUX Expandable Interbody SystemXENIX MEDICAL LLCLXH2026-10-05
00840493441696RIVA Pedicle Screw SystemXENIX MEDICAL LLCLXH2026-10-05
00840493442020Xenix Medical Universal HandleXENIX MEDICAL LLCLXH2026-10-05
00840493442037Xenix Medical Universal HandleXENIX MEDICAL LLCLXH2026-10-05
00888867620612Arthrex®ARTHREX, INC.LXH2026-10-01
00888867620629Arthrex®ARTHREX, INC.LXH2026-10-01
00888867620636Arthrex®ARTHREX, INC.LXH2026-10-01
00888867620643Arthrex®ARTHREX, INC.LXH2026-10-01
M7401001380OptiLIF Endo, Direct Visualization SystemSPINEOLOGY INC.LXH2026-10-01
00840606191425PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00840606191432PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00840606191449PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00840606191456PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00810017915668SABER-XA, Trial InserterELEVATION SPINE, INC.LXH2026-09-29
00810017916030SABER-XA Straight Awl, Self-GuidedELEVATION SPINE, INC.LXH2026-09-29
00810055525300Onyx 4.5mm Cannulated TapSi-Bone Inc.LXH2026-09-29
00810055525317Onyx 5.5mm Cannulated TapSi-Bone Inc.LXH2026-09-29
10888857615694CHESAPEAKE® Stabilization SystemVB Spine LLCLXH2026-09-23