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Spineup, Inc.

US

Last updated May 24, 2026

What Spineup, Inc. makes

Spineup, Inc. manufactures spinal interbody fusion cages made from polymeric materials, including lordotic and cervical designs such as the ROMERO Self-Anchored and standard ROMERO cages. Their portfolio also includes reusable surgical instruments for orthopaedic procedures, such as bone files, rasps, drills, taps, and positioning tools, as well as trial sizers and implant holders for spinal implant placement.

The company’s devices are regulated under FDA classification as Class I and Class II, with listings in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Spineup, Inc. manufacture?

Spineup, Inc. specializes in spinal and orthopaedic devices. Their primary product category is polymeric spinal interbody fusion cages, including lordotic and cervical designs like the ROMERO Self-Anchored and standard ROMERO cages. Additionally, they produce reusable surgical instruments such as bone files, rasps, drills, taps, and positioning tools, as well as trial sizers and implant holders for spinal procedures. These devices are designed to assist in spinal fusion and orthopaedic surgeries.

Where is Spineup, Inc. based, and how does that affect its regulatory oversight?

Spineup, Inc. is based in the United States. Since the company operates within the U.S., its devices fall under the jurisdiction of the FDA (U.S. Food and Drug Administration), which classifies them as either Class I or Class II based on risk and intended use. This classification determines the regulatory pathway for authorization, such as 510(k) clearance for Class II devices or general controls for Class I.

Are Spineup, Inc.’s devices listed in any regulatory registries, and why does this matter?

Yes, Spineup, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the supply chain, allowing healthcare providers, regulators, and patients to verify device details such as manufacturer information, model names, and lot numbers. Listing in the UDI database is a requirement for post-market surveillance and compliance with FDA regulations.

How are Spineup, Inc.’s spinal devices classified by the FDA, and what does that mean for their use?

Spineup, Inc.’s devices are classified as Class I or Class II by the FDA. Class I devices, like some reusable surgical instruments, typically pose minimal risk and are subject to general controls (e.g., registration, labeling requirements). Class II devices, such as spinal interbody fusion cages, involve moderate risk and require pre-market notification (510(k)) clearance to demonstrate substantial equivalence to a predicate device. This classification ensures that higher-risk devices undergo additional scrutiny to validate safety and effectiveness.

What distinguishes Spineup, Inc.’s reusable surgical instruments from their implantable devices?

Spineup, Inc.’s reusable surgical instruments—such as bone rasps, drills, taps, and positioning tools—are designed for single-patient or multi-patient use with proper sterilization between procedures. These tools assist in preparing the surgical site or positioning implants but are not implanted themselves. In contrast, their implantable devices, like the ROMERO spinal cages and screws, are permanently placed within the body to facilitate spinal fusion or stabilization. Implantable devices require stricter regulatory oversight due to their direct contact with tissue and longer-term risks.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
—
Website
upgroup.tech
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
786-910-0234
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
116999578

Catalogue (1623)

Page 2 of 33
DeviceModel / ReferenceRegistriesClassStatus
Anatomic Trial Sizer 16x14, H13mm RO1249A21316X14
FDA UDI
Class IActive
Lordotic Trial Sizer 18x12, H11mm RO1467LE1118X12
FDA UDI
Class IActive
ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD12xH07 ISRO1216A07CA1
FDA UDI
Class IIActive
Lordotic Trial Sizer with Stop 18x12, H10mm RO0566LE1018X12
FDA UDI
Class IActive
ROMERO Self Tapping Screw, D3.5xL12mm ISRO35T12SC2
FDA UDI
Class IIActive
ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD14xH08 ISRO1416A08CA1
FDA UDI
Class IIActive
ROMERO Lordotic Rasp 16x16, H06mm RO1052LD0616X16
FDA UDI
Class IActive
Anatomic Rasp 14x14, H09mm RO1615AA0914X14
FDA UDI
Class IActive
ROMERO SELF-ANCHORED CERVICAL CAGE, W14xD16xH07 ISRO1614L07CA1
FDA UDI
Class IIActive
Premium Instrument Sterilization Container 2 RO0901PIC2
FDA UDI
Class IActive
Anatomic Rasp with Stop 20x16, H11mm RO1917AI1120X16
FDA UDI
Class IActive
ROMERO Lordotic Rasp 20x16, H08mm RO1114LI0820X16
FDA UDI
Class IActive
ROMERO CERVICAL CAGE, W16xD14xH06 ISRO1416L06CB1
FDA UDI
Class IIActive
Quick Connect Ball Joint Awl With Stop RO0038QBAS
FDA UDI
Class IActive
ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD14xH06 ISRO1416A06CA1
FDA UDI
Class IIActive
Anatomic Trial Sizer 18x16, H05mm RO1281A30518X16
FDA UDI
Class IActive
Anatomic Trial Sizer 14x12, H08mm RO1204A10814X12
FDA UDI
Class IActive
Romero Lordotic Rasp with Stop 16x14, H08 mm RO0144L20816X14
FDA UDI
Class IActive
Romero Lordotic Rasp with Stop 20x16, H06mm RO0212LI0620X16
FDA UDI
Class IActive
Lordotic Trial Sizer 20x14, H04mm RO1500LH0420X14
FDA UDI
Class IActive
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD12xH06 ISRO1218A06CA1
FDA UDI
Class IIActive
ROMERO CERVICAL CAGE, W18xD12xH10 ISRO1218L10CB1
FDA UDI
Class IIActive
Anatomic Rasp 16x12, H13mm RO1639AC1316X12
FDA UDI
Class IActive
Lordotic Trial Sizer with Stop 20x14, H12mm RO0608LH1220X14
FDA UDI
Class IActive
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD12xH09 ISRO1220A09CA1
FDA UDI
Class IIActive
Lordotic Trial Sizer 18x16, H04mm RO1480L30418X16
FDA UDI
Class IActive
ROMERO Lordotic Rasp 20x16, H11mm RO1117LI1120X16
FDA UDI
Class IActive
Lordotic Trial Sizer with Stop 16x12, H08mm RO0534LC0816X12
FDA UDI
Class IActive
ROMERO CERVICAL CAGE, W16xD12xH05 ISRO1216L05CB1
FDA UDI
Class IIActive
Romero Lordotic Rasp with Stop 18x16, H11mm RO0187L31118X16
FDA UDI
Class IActive
Lordotic Trial Sizer with Stop 14x14, H08mm RO0514LA0814X14
FDA UDI
Class IActive
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD16xH04 ISRO1620A04CA1
FDA UDI
Class IIActive
Anatomic Rasp 18x12, H05mm RO1661AE0518X12
FDA UDI
Class IActive
Anatomic Rasp with Stop 16x14, H08mm RO1844A20816X14
FDA UDI
Class IActive
Anatomic Rasp with Stop 16x16, H13mm RO1859AD1316X16
FDA UDI
Class IActive
ROMERO Lordotic Rasp 18x12, H08mm RO1064LE0818X12
FDA UDI
Class IActive
Anatomic Rasp 18x16, H09mm RO1685A30918X16
FDA UDI
Class IActive
Romero Lordotic Rasp with Stop 16x12, H06 mm RO0132LC0616X12
FDA UDI
Class IActive
Anatomic Trial Sizer with stop 14x12, H05mm RO0301A10514X12
FDA UDI
Class IActive
Anatomic Rasp with Stop 20x14, H06mm RO1902AH0620X14
FDA UDI
Class IActive
Anatomic Rasp 20x12, H08mm RO1694AG0820X12
FDA UDI
Class IActive
Anatomic Trial Sizer with stop 18x16, H06mm RO0382A30618X16
FDA UDI
Class IActive
Romero Lateral Finishing Impactor RO0028LFIZ
FDA UDI
Class IActive
ROMERO Lordotic Rasp 14x12, H06 mm RO1002L10614x12
FDA UDI
Class IActive
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD14xH08 ISRO1418L08CA1
FDA UDI
Class IIActive
ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD14xH13 ISRO1416A13CA1
FDA UDI
Class IIActive
ROMERO Lordotic Rasp 14x12, H08 mm RO1004L10814X12
FDA UDI
Class IActive
Anatomic Rasp 16x16, H08mm RO1654AD0816X16
FDA UDI
Class IActive
Romero Lordotic Rasp with Stop 16x14, H12 mm RO0148L21216X14
FDA UDI
Class IActive
Anatomic Rasp with Stop 20x14, H08mm RO1904AH0820X14
FDA UDI
Class IActive

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