FDA.reportPublic FDA data

OptiMesh Multiplanar Expandable Interbody Fusion System

Primary DI
M7403120064
Brand
OptiMesh Multiplanar Expandable Interbody Fusion System
Company
SPINEOLOGY INC.
Model
32-01-50
Catalog number
312-0064
Device description
Reduced Diameter Mesh Extender
Published
2025-03-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OQBIntervertebral Body Graft Containment Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OQBIntervertebral Body Graft Containment DeviceOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231781000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231781000OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.2023-10-18OQB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7403120064PrimaryHIBCC0

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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M7401001380OptiLIF Endo, Direct Visualization System102-90-01100-13802026-10-01
M7401001376Threshold Pedicular Fixation System102-88-01100-13762026-08-21
M7401001377Threshold Pedicular Fixation System102-88-02100-13772026-08-21
M7401001378Threshold Pedicular Fixation System102-88-03100-13782026-08-21
M7409200004MIS TLIF System92-02-01920-00042026-08-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M7407002625OptiMesh HA Nano Multiplanar Expandable Interbody Fusion SystemSPINEOLOGY INC.OQB2025-12-19
M7405002628OptiMesh HA Nano Multiplanar Expandable Interbody Fusion SystemSPINEOLOGY INC.OQB2025-12-19
M7405003032OptiMesh HA Nano Multiplanar Expandable Interbody Fusion SystemSPINEOLOGY INC.OQB2025-12-19
M7405003440OptiMesh HA Nano Multiplanar Expandable Interbody Fusion SystemSPINEOLOGY INC.OQB2025-12-19
M7401001342OptiMesh Multiplanar Expandable Interbody Fusion SystemSPINEOLOGY INC.OQB2025-06-30
M7404002625OptiMesh Multiplanar Expandable Interbody Fusion SystemSPINEOLOGY INC.OQB2025-03-19
M7401001286OptiMesh Multiplanar Expandable Interbody Fusion SystemSPINEOLOGY INC.OQB2024-05-24
M7404002620Dual Chamber Expandable Interbody Fusion SystemSPINEOLOGY INC.OQB2024-02-21
M740227005OptiMesh Multiplanar Expandable Interbody Fusion SystemSPINEOLOGY INC.OQB2024-02-21
M7404002610Dual Chamber Expandable Interbody Fusion SystemSPINEOLOGY INC.OQB2024-02-21
M7401011081Diverted Bone TubeSPINEOLOGY INC.OQB2022-06-22
M7403001015OptiMesh Expandable Interbody Fusion SystemSPINEOLOGY INC.OQB2021-03-17
M7403001008OptiMesh Expandable Interbody Fusion SystemSPINEOLOGY INC.OQB2021-03-17
M7403001012OptiMesh Expandable Interbody Fusion SystemSPINEOLOGY INC.OQB2021-03-17
M7403002628OptiMesh Expandable Interbody Fusion SystemSPINEOLOGY INC.OQB2021-03-17
M7403003032OptiMesh Expandable Interbody Fusion SystemSPINEOLOGY INC.OQB2021-03-17
M7403003440OptiMesh Expandable Interbody Fusion SystemSPINEOLOGY INC.OQB2021-03-17
M7403120001OptiMesh Expandable Interbody Fusion SystemSPINEOLOGY INC.OQB2021-03-17
M7403120003OptiMesh Expandable Interbody Fusion SystemSPINEOLOGY INC.OQB2021-03-17
M7403120004OptiMesh Expandable Interbody Fusion SystemSPINEOLOGY INC.OQB2021-03-17
M7403120055OptiMesh Expandable Interbody Fusion SystemSPINEOLOGY INC.OQB2021-03-17