FDA.reportPublic FDA data

SiLO TFX MIS Sacroiliac Joint Fixation System

Primary DI
B521114310010
Brand
SiLO TFX MIS Sacroiliac Joint Fixation System
Company
AURORA SPINE, INC.
Model
114-310-01
Device description
SiLO TFX Inserter Adapter
Published
2024-08-13
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221047000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221047000SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.2022-10-03OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B521114310010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Sacroiliac joint transarticular fixation/arthrodesis implantation kitA collection of surgical instruments and devices intended to be used for the implantation of a sacroiliac joint transarticular fixation/arthrodesis implant during a minimally-invasive procedure. It typically consists of a tray, dedicated soft-tissue protectors, depth gauges, pin sleeves, drill sleeves, drill bits, broaches, a parallel pin guide, handles, slide hammer shafts, impactors, and a removal/adaptor tool; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
760.424.2004info@auroraspine.us

Regulatory Flags#

DUNS number
079119091
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B521115001100Apollo Anterior Cervical Plate System115-001-102024-08-13
B521115001120Apollo Anterior Cervical Plate System115-001-122024-08-13
B521115001140Apollo Anterior Cervical Plate System115-001-142024-08-13
B521115001160Apollo Anterior Cervical Plate System115-001-162024-08-13
B521115001180Apollo Anterior Cervical Plate System115-001-182024-08-13
B521115001200Apollo Anterior Cervical Plate System115-001-202024-08-13
B521115001220Apollo Anterior Cervical Plate System115-001-222024-08-13
B521115001240Apollo Anterior Cervical Plate System115-001-242024-08-13
B521115001260Apollo Anterior Cervical Plate System115-001-262024-08-13
B521115002260Apollo Anterior Cervical Plate System115-002-262024-08-13
B521115002280Apollo Anterior Cervical Plate System115-002-282024-08-13
B521115002300Apollo Anterior Cervical Plate System115-002-302024-08-13
B521115002320Apollo Anterior Cervical Plate System115-002-322024-08-13
B521115002340Apollo Anterior Cervical Plate System115-002-342024-08-13
B521115002360Apollo Anterior Cervical Plate System115-002-362024-08-13
B521115002380Apollo Anterior Cervical Plate System115-002-382024-08-13
B521115002400Apollo Anterior Cervical Plate System115-002-402024-08-13
B521115002420Apollo Anterior Cervical Plate System115-002-422024-08-13
B521115003390Apollo Anterior Cervical Plate System115-003-392024-08-13
B521115003420Apollo Anterior Cervical Plate System115-003-422024-08-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840286860093Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00840286860109Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00840286860116Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
10705034647463N/AMedos International SàrlLXH2026-07-09
B382SD49400B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49401B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49402B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49403B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49404B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49405B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49406B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49407B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49408B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49409B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49410B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49411B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49412B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49413B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49414B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49415B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49416B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49417B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49418B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49419B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49420B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500010Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500020Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500030Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500040Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500050Surgical DirectSurgical Direct, Inc.LXH2026-07-09