FDA.reportPublic FDA data

Threshold Pedicular Fixation System

Primary DI
M7405530027
Brand
Threshold Pedicular Fixation System
Company
SPINEOLOGY INC.
Model
10-64-02
Catalog number
553-0027
Device description
Top, Sterilization Tray
Published
2024-01-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7405530027PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
651-256-8500info@spineology.com

Regulatory Flags#

DUNS number
033014361
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M7403030001Discectomy Set10-01-138303-00012026-07-08
M7403030002Discectomy Set10-01-139303-00022026-07-08
M7403030069Discectomy Set15-01-58303-00692026-07-08
M7403030070Discectomy Set15-01-59303-00702026-07-08
M7403030071Discectomy Set15-01-60303-00712026-07-08
M7404300035CAPTURE Facet Screw Set System70-02-008-1430-00352026-05-29
M7403030028Discectomy Set15-01-45-1303-00282026-05-28
M7403030029Discectomy Set15-01-45-2303-00292026-05-28
M7403030030Discectomy Set15-01-45-3303-00302026-05-28
M7403030031Discectomy Set15-01-45-4303-00312026-05-28
M7403030032Discectomy Set15-01-45-5303-00322026-05-28
M7403030033Discectomy Set15-01-45-6303-00332026-05-28
M7403030034Discectomy Set15-01-45-7303-00342026-05-28
M7403030035Discectomy Set15-01-45-8303-00352026-05-28
M7403030036Discectomy Set15-01-45-9303-00362026-05-28
M7403030059Discectomy Set15-01-45-10303-00592026-05-28
M7403030060Discectomy Set15-01-45-11303-00602026-05-28
M7401001373MIS TLIF System102-86-01100-13732026-05-21
M7401001371OptiLIF Endo, Direct Visualization System102-84-01100-13712026-04-06
M7406410015Fortress Pedicular Fixation64-02-01641-00152024-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810130207435MSIModern Surgical Instruments LLCLXH2026-07-14
00840606188128Ventana ASPINAL ELEMENTS, INC.LXH2026-07-13
08809695601903AnyPlus®GS Medical Co., Ltd.LXH2026-04-21
08800322742945PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322742952PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322742969PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322742976PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322742983PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322742990PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743003PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743010PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743027PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743034PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743041PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743058PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743065PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743072PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743089PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743096PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743102PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743119PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743126PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743133PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743140PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743157PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743171PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743188PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743195PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743201PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743218PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18