Question 1

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

Accepted Answer

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.

Question 2

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

Accepted Answer

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.

Question 3

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

Accepted Answer

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.

Question 4

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

Accepted Answer

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.

Question 5

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

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
Anatomic Trial Sizer with stop 14x12, H13mm	RO0309A11314X12	FDA UDI	Class I	Active
Anatomic Trial Sizer 18x14, H13mm	RO1279AF1318X14	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 16x16, H05mm	RO0351AD0516X16	FDA UDI	Class I	Active
Anatomic Trial Sizer 14x16, H04mm	RO1220AB0414X16	FDA UDI	Class I	Active
Anatomic Rasp 16x12, H10mm	RO1636AC1016X12	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 16x12, H11 mm	RO0137LC1116X12	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W14xD12xH09	ISRO1214L09CB1	FDA UDI	Class II	Active
Romero Lordotic Rasp with Stop 18x12, H05mm	RO0161LE0518X12	FDA UDI	Class I	Active
Anatomic Rasp with Stop 20x16, H06mm	RO1912AI0620X16	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W20xD16xH10	ISRO1620A10CB1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W18xD12xH10	ISRO1218A10CB1	FDA UDI	Class II	Active
ROMERO Lordotic Rasp 18x12, H10mm	RO1066LE1018X12	FDA UDI	Class I	Active
Anatomic Rasp with Stop 14x12, H10mm	RO1806AI1014X12	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W16xD12xH04	ISRO1216A04CB1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD16xH07	ISRO1616A07CA1	FDA UDI	Class II	Active
Ball Joint Drill with Stop D3.5xL16	RO2008F116	FDA UDI	Class I	Active
Anatomic Rasp 14x14, H07mm	RO1613AA0714X14	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 18x12, H08mm	RO0364AE0818X12	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 20x12, H07mm	RO0393AG0720X12	FDA UDI	Class I	Active
Anatomic Rasp 16x12, H12mm	RO1638AC1216X12	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 18x16, H07mm	RO0583L30718X16	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W14xD12xH07	ISRO1214L07CA1	FDA UDI	Class II	Active
Anatomic Rasp 16x12, H04mm	RO1630AC0416X12	FDA UDI	Class I	Active
Lordotic Trial Sizer 14x12, H08mm	RO1404L10814X12	FDA UDI	Class I	Active
Lordotic Trial Sizer 18x14, H08mm	RO1474LF0818X14	FDA UDI	Class I	Active
Anatomic Trial Sizer 20x16, H13mm	RO1319AI1320X16	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 18x16, H07mm	RO0383A30718X16	FDA UDI	Class I	Active
Anatomic Trial Sizer 16x12, H06mm	RO1232AC0616X12	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 14x16, H08 mm	RO0124LB0814X16	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 18x14, H13mm	RO0379AF1318X14	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W20xD16xH04	ISRO1620A04CB1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W14xD16xH08	ISRO1614L08CA1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W14xD14xH12	ISRO1414A12CA1	FDA UDI	Class II	Active
Narrow Introducer for Extended Heights	RO0004NIEH	FDA UDI	Class I	Active
Anatomic Rasp with Stop 14x12, H09mm	RO1805AI0914X12	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W14xD14xH08	ISRO1414A08CB1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W18xD16xH06	ISRO1618L06CB1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W18xD14xH08	ISRO1418A08CB1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W20xD14xH05	ISRO1420L05CB1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W14xD16xH07	ISRO1614L07CB1	FDA UDI	Class II	Active
Lordotic Trial Sizer 14x16, H13mm	RO1429LB1314X16	FDA UDI	Class I	Active
Anatomic Trial Sizer 20x12, H05mm	RO1291AG0520X12	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD16xH04	ISRO1620L04CA1	FDA UDI	Class II	Active
Romero Lordotic Rasp with Stop 14x12, H13 mm	RO0109L11314X12	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 18x16, H05mm	RO1081L30518X16	FDA UDI	Class I	Active
Anatomic Trial Sizer 18x12, H05mm	RO1261AE0518X12	FDA UDI	Class I	Active
Implant Holder with Drill Guides W20 x H09 mm	RO0835I409	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 14x12, H12 mm	RO0108L11214X12	FDA UDI	Class I	Active
Anatomic Trial Sizer 16x14, H08mm	RO1244A20816X14	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W14xD14xH04	ISRO1414A04CB1	FDA UDI	Class II	Active

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