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
Lordotic Trial Sizer 16x14, H13mm	RO1449L21316X14	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 14x16, H11mm	RO0527LB1114X16	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 18x14, H12mm	RO0378AF1218X14	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W18xD14xH13	ISRO1418L13CB1	FDA UDI	Class II	Active
ROMERO Lordotic Rasp 14x14, H13mm	RO1019LA1314X14	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 16x16, H10mm	RO0556LD1016X16	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 20x12, H12mm	RO0198LG1220X12	FDA UDI	Class I	Active
Anatomic Rasp 16x12, H05mm	RO1631AC0516X12	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 20x16, H07mm	RO0613LI0720X16	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W18xD16xH09	ISRO1618L09CB1	FDA UDI	Class II	Active
Large AO Quick Connect Handle	GN0006LAQC	FDA UDI	Class I	Active
ROMERO Self Drilling Screw, D3.5xL13mm	ISRO35D13SC2	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD16xH09	ISRO1616A09CA1	FDA UDI	Class II	Active
Anatomic Trial Sizer with stop 18x12, H11mm	RO0367AE1118X12	FDA UDI	Class I	Active
Anatomic Rasp 16x14, H11mm	RO1647A21116X14	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 14x16, H11mm	RO0327AB1114X16	FDA UDI	Class I	Active
Romero Large Introducer for Extended Heights	RO0006LIEH	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD16xH06	ISRO1616L06CA1	FDA UDI	Class II	Active
Anatomic Trial Sizer 20x12, H13mm	RO1299AG1320X12	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W14xD14xH09	ISRO1414A09CA1	FDA UDI	Class II	Active
Lordotic Trial Sizer with Stop 18x16, H11mm	RO0587L31118X16	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD16xH09	ISRO1620A09CA1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD14xH12	ISRO1416A12CA1	FDA UDI	Class II	Active
ROMERO Lordotic Rasp 18x14, H07mm	RO1073LF0718X14	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 18x16, H08mm	RO0384A30818X16	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 18x12, H09mm	RO0365AE0918X12	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 18x12, H04mm	RO0160LE0418X12	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W14xD12xH08	ISRO1214A08CA1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W18xD14xH06	ISRO1418A06CB1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W14xD16xH13	ISRO1614A13CA1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W14xD12xH09	ISRO1214A09CB1	FDA UDI	Class II	Active
Lordotic Trial Sizer 16x16, H10mm	RO1456LD1016X16	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD14xH11	ISRO1416A11CA1	FDA UDI	Class II	Active
Lordotic Trial Sizer 20x16, H07mm	RO1513LI0720X16	FDA UDI	Class I	Active
Anatomic Rasp 14x16, H05mm	RO1621AB0514X16	FDA UDI	Class I	Active
Anatomic Trial Sizer 18x16, H11mm	RO1287A31118X16	FDA UDI	Class I	Active
Lordotic Trial Sizer 20x12, H04mm	RO1490LG0420X12	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 14x14, H112 mm	RO0118LA1214X14	FDA UDI	Class I	Active
Anatomic Trial Sizer 16x16, H05mm	RO1251AD0516X16	FDA UDI	Class I	Active
Anatomic Rasp 16x16, H07mm	RO1653AD0716X16	FDA UDI	Class I	Active
Anatomic Trial Sizer 20x14, H05mm	RO1301AH0520X14	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 16x14, H06mm	RO0342A20616X14	FDA UDI	Class I	Active
Anatomic Rasp 14x12, H07mm	RO1603A10714X12	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 16x16, H08mm	RO0154LD0816X16	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W18xD14xH07	ISRO1418L07CB1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W14xD16xH04	ISRO1614A04CB1	FDA UDI	Class II	Active
Lordotic Trial Sizer 20x12, H10mm	RO1496LG1020X12	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 16x14, H05mm	RO1041L20516X14	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 16x12, H04mm	RO1030LC0416X12	FDA UDI	Class I	Active
Cervical Tap Primary with Stop L21	GN0063T121	FDA UDI	Class I	Active

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