Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021180147

FEI Number

3021180147

Entity Name

SPINEUP INC

City/State/Country

Miami, FL, US

Establishment Address

2116 Nw 13th Ave, Ste 202, Miami, FL 33142, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

SpineUp Inc (Owner Number: 10085441)

Owner / Operator Contact Address

2116 Nw 13th Ave, Ste 202, Miami, FL 33142, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K212358

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2022-06-17
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2022-06-17

Official Correspondent

Philippe Laurito

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SpineUp Inc

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

Similar Registrations

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3012447612	Highridge Medical, LLC	Westminster, CO, US
3016084569	MOUNT MFG	Marquette, MI, US
1424263	Isomedix Operations, Inc.	Libertyville, IL, US
3018210489	NEXUS SPINE, LLC.	Draper, UT, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021180147. Last updated year: 2026. Please use registration number 3021180147 when referencing this establishment in official correspondence.