FDA.reportPublic FDA data

Universal Dilator

Primary DI
M7405210002
Brand
Universal Dilator
Company
SPINEOLOGY INC.
Model
52-02-09
Catalog number
521-0002
Device description
Pedicle Markers
Published
2023-12-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXNProbe, Test, Heart-Valve

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXNProbe, Test, Heart-ValveCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7405210002PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

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
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
M7406410071Fortress Pedicular Fixation55-03-20641-00712024-01-10
M7408610084Duo Expandable Interbody Fusion System86-11-51861-00842023-12-28
M7407408599Fortress Pedicale Screw10-10-57-45740-85992015-09-17
M7407404525Fortress Pedicale Screw10-10-57-1740-45252015-09-17
M7407404530Fortress Pedicale Screw10-10-57-2740-45302015-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M7408606028Duo Ti Expandable Interbody Fusion SystemSPINEOLOGY INC.LXN2023-12-29
M7405230003Universal Dilator SPINEOLOGY INC.LXN2023-12-19
00851788001167On-X Heart Valve InstrumentsON-X LIFE TECHNOLOGIES, INC.LXN2023-08-09
05415067042316NAST. JUDE MEDICAL, INC.LXN2023-05-19
15415067042313NAST. JUDE MEDICAL, INC.LXN2023-05-19
00896208000269Leaflet TesterCorcym Canada CorpLXN2021-04-20
M944AL105710Wexler Surgical, Inc.WEXLER SURGICAL, INC.LXN2020-07-31
00886333222940Bone Access NeedleARGON MEDICAL DEVICES, INC.LXN2016-09-21
20886333222944Bone Access NeedleARGON MEDICAL DEVICES, INC.LXN2016-09-21