Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009446038

FEI Number

3009446038

Entity Name

NANOVIS SPINE, LLC

City/State/Country

Columbia City, IN, US

Establishment Address

5865 E State Road 14, Columbia City, IN 46725, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Nanovis, LLC (Owner Number: 10039378)

Owner / Operator Contact Address

5865 E State Road 14, Columbia City, IN 46725, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Nanovis Spine Posterior Interbody Fusion Spacer Nanovis Spine Transforminal Interbody Fusion Spacer Nanovis Spine Cervical Interbody Fusion Spacer Nanovis Spine TLIF Implant Trial Nanovis Spine Cervical Implant Trial Ortho Access Spine Transforminal Interbody Fusion Spacer Nanovis Spine Cervical Interbody spacer insertion tool Nanovis Spine PLIF Interbody spacer insertion tool Nanovis Spine TLIF Interbody spacer insertion tool Nanovis Spine PLIF Implant Trial Nanovis FortiCore PLIF Spacer Nanovis Cervical Tamp Nanovis TLIF Tamp Nanovis PLIF Tamp Nanovis Bone Funnel Tamp Nanovis Screwdriver Nanovis Screw Extractor Nanovis FortiBridge Anterior Cervical Plate FortiCore® Nanovis Bone Awl Adaptix PEEK Interbody System with Nanotechnology Nano FortiFix Nano FortiCore Nanovis Plate Bender

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2012-01-03
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2012-01-03
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2016-09-13
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2016-09-13
HXG	Tamp	Orthopedic	Class 1	888.4540	2015-04-07
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2015-05-12
HWB	Extractor	Orthopedic	Class 1	888.4540	2015-05-12
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2016-10-26
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2018-03-05
HWJ	Awl	Orthopedic	Class 1	888.4540	2015-04-07
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2024-10-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2021-01-12
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2023-09-14
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2023-09-14
HXW	Bender	Orthopedic	Class 1	888.4540	2015-05-12

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Nanovis, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K142269	Reliance Medical Systems, LLC	Reliance Cervical IBF System	2015-06-09
K122085	Omni Surgical, LP Dba Spine360	STINGRAY CERVICAL CAGE	2012-10-17
K120275	Synthes (Usa), LLC	SYNTHES ACIS/VERTEBRAL SPACER CR	2012-05-25
K223430	Life Spine, Inc.	ProLift Micro Expandable Spacer System	2023-05-04
K102293	Globus Medical, Inc.	CALIBER SPACER	2011-01-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2013	Medtronic Sofamor Danek USA Inc	2	ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0037-2013	Medtronic Sofamor Danek USA Inc	2	ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0038-2013	Medtronic Sofamor Danek USA Inc	2	PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0040-05	Zimmer Spine, Inc.	2	ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.
Z-0001-2013	Synthes USA HQ, Inc.	2	MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).

Similar Registrations

Registration Number	Establishment Name	Location
3021588295	XYRESIC LLC	Jackson, MI, US
3036496433	SPECTRUM SPINE INC	Jasper, GA, US
3027726367	HAPPE SPINE	Grand Rapids, MI, US
3027201862	XCIX DESIGN, LLC	Richmond, UT, US
3017936978	CARLSMED, INC.	Carlsbad, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009446038. Last updated year: 2026. Please use registration number 3009446038 when referencing this establishment in official correspondence.