Spineology Navigation Instruments 161-0033

GUDID M7401610033

Navigation Adapter

SPINEOLOGY INC.

Bone-screw internal spinal fixation system, sterile
Primary Device IDM7401610033
NIH Device Record Keya66fe45f-2a0c-45a6-ad94-f034ac1b3b06
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpineology Navigation Instruments
Version Model Number16-08-01
Catalog Number161-0033
Company DUNS033014361
Company NameSPINEOLOGY INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone6512568500
Emailinfo@spineology.com
Phone6512568500
Emailinfo@spineology.com
Phone6512568500
Emailinfo@spineology.com
Phone6512568500
Emailinfo@spineology.com
Phone6512568500
Emailinfo@spineology.com
Phone6512568500
Emailinfo@spineology.com
Phone6512568500
Emailinfo@spineology.com
Phone6512568500
Emailinfo@spineology.com
Phone6512568500
Emailinfo@spineology.com
Phone6512568500
Emailinfo@spineology.com
Phone6512568500
Emailinfo@spineology.com
Phone6512568500
Emailinfo@spineology.com
Phone6512568500
Emailinfo@spineology.com
Phone6512568500
Emailinfo@spineology.com
Phone6512568500
Emailinfo@spineology.com
Phone6512568500
Emailinfo@spineology.com
Phone6512568500
Emailinfo@spineology.com
Phone6512568500
Emailinfo@spineology.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM7401610033 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M7401610033]

Moist Heat or Steam Sterilization

[M7401610033]

Moist Heat or Steam Sterilization

[M7401610033]

Moist Heat or Steam Sterilization

[M7401610033]

Moist Heat or Steam Sterilization

[M7401610033]

Moist Heat or Steam Sterilization

[M7401610033]

Moist Heat or Steam Sterilization

[M7401610033]

Moist Heat or Steam Sterilization

[M7401610033]

Moist Heat or Steam Sterilization

[M7401610033]

Moist Heat or Steam Sterilization

[M7401610033]

Moist Heat or Steam Sterilization

[M7401610033]

Moist Heat or Steam Sterilization

[M7401610033]

Moist Heat or Steam Sterilization

[M7401610033]

Moist Heat or Steam Sterilization

[M7401610033]

Moist Heat or Steam Sterilization

[M7401610033]

Moist Heat or Steam Sterilization

[M7401610033]

Moist Heat or Steam Sterilization

[M7401610033]

Moist Heat or Steam Sterilization

[M7401610033]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-05-03
Device Publish Date2018-09-24

Devices Manufactured by SPINEOLOGY INC.

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M7401001300 - Threshold V2 Pedicular Fixation System2025-07-10 Straight Lumbar Probe
M7401001301 - Threshold V2 Pedicular Fixation System2025-07-10 Curved Duckbill Probe
M7401001336 - OptiMesh Multiplanar Expandable Interbody Fusion System2025-07-08 TLIF Portal Anchor, Midline 4mm
M7401001338 - OptiMesh Multiplanar Expandable Interbody Fusion System2025-07-08 TLIF Portal Anchor, Angled 4mm
M7401001339 - OptiMesh Multiplanar Expandable Interbody Fusion System2025-07-08 Modified Portal Stem
M7401001342 - OptiMesh Multiplanar Expandable Interbody Fusion System2025-07-08 Universal 2.0 Inserter Ref. Assembly
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