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 Rasp 18x16, H07mm	RO1683A30718X16	FDA UDI	Class I	Active
Anatomic Trial Sizer 18x14, H04mm	RO1270AF0418X14	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W18xD12xH06	ISRO1218L06CB1	FDA UDI	Class II	Active
Romero Lordotic Rasp with Stop 18x12, H13mm	RO0169LE1318X12	FDA UDI	Class I	Active
Anatomic Rasp 20x16, H05mm	RO1711AI0520X16	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 20x12, H07mm	RO0593LG0720X12	FDA UDI	Class I	Active
Cervical Tap Primary with Stop L20	GN0062T120	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 20x12, H04mm	RO1100LH0420X14	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W16xD14xH12	ISRO1416A12CB1	FDA UDI	Class II	Active
Anatomic Rasp 20x14, H07mm	RO1703AH0720X14	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD12xH04	ISRO1218L04CA1	FDA UDI	Class II	Active
Anatomic Rasp 20x12, H07mm	RO1693AG0720X12	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 16x14, H05mm	RO0341A20516X14	FDA UDI	Class I	Active
Lordotic Trial Sizer 20x14, H10mm	RO1506LH1020X14	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W16xD12xH05	ISRO1216A05CB1	FDA UDI	Class II	Active
Lordotic Trial Sizer with Stop 18x14, H04mm	RO0570LF0418X14	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 18x14, H07mm	RO0173LF0718X14	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD12xH12	ISRO1216L12CA1	FDA UDI	Class II	Active
Lordotic Trial Sizer 20x12, H12mm	RO1498LG1220X12	FDA UDI	Class I	Active
Anatomic Rasp 14x16, H04mm	RO1620AB0414X16	FDA UDI	Class I	Active
Anatomic Trial Sizer 18x16, H10mm	RO1286A31018X16	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 20x16, H08mm	RO0414AI0820X16	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 16x16, H05mm	RO0151LD0516X16	FDA UDI	Class I	Active
Lordotic Trial Sizer 16x12, H04mm	RO1430LC0416X12	FDA UDI	Class I	Active
Anatomic Trial Sizer 14x14, H09mm	RO1215AA0914X14	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W16xD12xH13	ISRO1216L13CB1	FDA UDI	Class II	Active
Anatomic Trial Sizer 16x14, H06mm	RO1242A20616X14	FDA UDI	Class I	Active
Anatomic Rasp with Stop 14x14, H04mm	RO1810AA0414X14	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD14xH09	ISRO1420L09CA1	FDA UDI	Class II	Active
Anatomic Rasp 16x16, H10mm	RO1656AD1016X16	FDA UDI	Class I	Active
Anatomic Rasp with Stop 18x12, H07mm	RO1863AE0718X12	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 14x16, H05mm	RO0321AB0514X16	FDA UDI	Class I	Active
Free Hand Introducer for Standard Heights (H < 10)	RO0031FHIS	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 16x16, H09mm	RO0355AD0916X16	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 20x12, H08mm	RO0394AG0820X12	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 16x14, H10mm	RO0546L21016X14	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD16xH13	ISRO1616L13CA1	FDA UDI	Class II	Active
Anatomic Trial Sizer with stop 14x14, H07mm	RO0313AA0714X14	FDA UDI	Class I	Active
Cervical Tap Primary with Stop L10	GN0052T110	FDA UDI	Class I	Active
Lordotic Trial Sizer 20x12, H08mm	RO1494LG0820X12	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 20x16, H04mm	RO0210LI0420X16	FDA UDI	Class I	Active
Free Hand Introducer for Extended Heights	RO0032FHIE	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD16xH09	ISRO1618A09CA1	FDA UDI	Class II	Active
Ball Joint Drill with Stop D3.5xL14	RO2006F114	FDA UDI	Class I	Active
Cervical Drill Primary with Stop L21	GN0083D121	FDA UDI	Class I	Active
Ball Joint Drill with Stop D3.5xL18	RO2110V118	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD14xH05	ISRO1420A05CA1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W14xD12xH09	ISRO1214L09CA1	FDA UDI	Class II	Active
Anatomic Trial Sizer 14x16, H08mm	RO1224AB0814X16	FDA UDI	Class I	Active
Ball Joint Drill with Stop D3.5xL09	RO2101V109	FDA UDI	Class I	Active

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