FDA.reportPublic FDA data

OptiMesh Multiplanar Expandable Interbody Fusion System

Primary DI
M743120021
Brand
OptiMesh Multiplanar Expandable Interbody Fusion System
Company
SPINEOLOGY INC.
Model
33-04-01
Catalog number
312-0021
Device description
Tube Ejector
Published
2023-09-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
M743120021PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic instrument extractorA hand-held manual surgical instrument designed to extract another orthopaedic instrument (e.g., instrument sleeve/guide) from a patient’s body during an orthopaedic surgical procedure. It is a robust instrument intended to clamp to the device intended to be extracted during the procedure; it is not intended for device introduction/insertion and is not intended for extraction of an implant. 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
00763000675028n/aMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-19
00824846002468Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-19
00763000837198Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-18
00199150041183N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00199150076024Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00763000891329Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00840314263636gSourceGSOURCE LLCLXH2026-07-17
00840314264190gSourceGSOURCE LLCLXH2026-07-17
00840314264268gSourceGSOURCE LLCLXH2026-07-17
00840314264404gSourceGSOURCE LLCLXH2026-07-17
00840314264473gSourceGSOURCE LLCLXH2026-07-17
00840314264541gSourceGSOURCE LLCLXH2026-07-17
00840314264619gSourceGSOURCE LLCLXH2026-07-17
00840314264688gSourceGSOURCE LLCLXH2026-07-17
00889929072219NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072226NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072233NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072264NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072271NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072288NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072295NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072301NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072318NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072325NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072332NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072349Matrixx SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072356NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072363NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072394NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072448Matrixx SystemNEXXT SPINE, LLCLXH2026-07-17