FDA.reportPublic FDA data

OptiMesh HA Nano Multiplanar Expandable Interbody Fusion System

Primary DI
M7407002625
Brand
OptiMesh HA Nano Multiplanar Expandable Interbody Fusion System
Company
SPINEOLOGY INC.
Model
32-01-37-7
Catalog number
700-2625
Device description
OptiMesh HA Nano Align, Extra Large
Published
2025-12-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
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
K251302000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251302000OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.2025-12-15OQB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7407002625PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Contacts#

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

Regulatory Flags#

DUNS number
033014361
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
M7407404535Fortress Pedicale Screw10-10-57-3740-45352015-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
M7403120064OptiMesh 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