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, H10mm	RO1446L21016X14	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W14xD12xH04	ISRO1214L04CB1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD16xH10	ISRO1620L10CA1	FDA UDI	Class II	Active
Lordotic Trial Sizer 16x12, H08mm	RO1434LC0816X12	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W20xD16xH06	ISRO1620L06CB1	FDA UDI	Class II	Active
ROMERO Self Tapping Screw, D4.0xL09mm	ISRO40T09SC2	FDA UDI	Class II	Active
ROMERO Lordotic Rasp 20x16, H06mm	RO1112LI0620X16	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W14xD16xH10	ISRO1614A10CB1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD14xH09	ISRO1420A09CA1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W14xD12xH07	ISRO1214L07CB1	FDA UDI	Class II	Active
Romero Lordotic Rasp with Stop 16x16, H09mm	RO0155LD0916X16	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 18x12, H13mm	RO0569LE1318X12	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W18xD14xH12	ISRO1418A12CB1	FDA UDI	Class II	Active
Romero Lordotic Rasp with Stop 20x12, H13mm	RO0199LG1320X12	FDA UDI	Class I	Active
Anatomic Rasp with Stop 14x16, H13mm	RO1829AB1314X16	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 18x16, H04mm	RO0380A30418X16	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W14xD16xH08	ISRO1614L08CB1	FDA UDI	Class II	Active
Anatomic Trial Sizer with stop 14x12, H07mm	RO0303A10714X12	FDA UDI	Class I	Active
Lordotic Trial Sizer 14x12, H09mm	RO1405L10914X12	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD16xH05	ISRO1616L05CA1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD12xH12	ISRO1220A12CA1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W20xD16xH06	ISRO1620A06CB1	FDA UDI	Class II	Active
Lordotic Trial Sizer with Stop 16x16, H08mm	RO0554LD0816X16	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD14xH11	ISRO1418L11CA1	FDA UDI	Class II	Active
Romero Lordotic Rasp with Stop 20x14, H08mm	RO0204LH0820X14	FDA UDI	Class I	Active
Anatomic Rasp with Stop 18x16, H09mm	RO1885A30918X16	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 18x16, H07mm	RO1083L30718X16	FDA UDI	Class I	Active
Lordotic Trial Sizer 20x16, H10mm	RO1516LI1020X16	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 18x16, H04mm	RO0580L30418X16	FDA UDI	Class I	Active
Anatomic Trial Sizer 14x16, H12mm	RO1228AB1214X16	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 16x14, H11mm	RO1047L21116X14	FDA UDI	Class I	Active
ROMERO Self Drilling Screw, D3.5xL14mm	ISRO35D14SC2	FDA UDI	Class II	Active
Anatomic Trial Sizer 16x12, H07mm	RO1233AC0716X12	FDA UDI	Class I	Active
Anatomic Rasp with Stop 18x16, H07mm	RO1883A30718X16	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 14x16, H010 mm	RO0126LB1014X16	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD12xH12	ISRO1220L12CA1	FDA UDI	Class II	Active
Lordotic Trial Sizer 16x16, H07mm	RO1453LD0716X16	FDA UDI	Class I	Active
Implant Holder with Drill Guides W18 x H07 mm	RO0823I307	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 18x16, H11mm	RO0387A31118X16	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 16x14, H09mm	RO0545L20916X14	FDA UDI	Class I	Active
Anatomic Rasp 16x14, H04mm	RO1640A20416X14	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W18xD12xH13	ISRO1218A13CB1	FDA UDI	Class II	Active
ROMERO Lordotic Rasp 20x12, H04mm	RO1090LG0420X12	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W16xD14xH13	ISRO1416L13CB1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD14xH07	ISRO1418L07CA1	FDA UDI	Class II	Active
Anatomic Rasp 20x14, H10mm	RO1706AH1020X14	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W16xD16xH11	ISRO1616A11CB1	FDA UDI	Class II	Active
Ball Joint Drill with Stop D3.5xL19	RO2111V119	FDA UDI	Class I	Active
ROMERO Self Tapping Screw, D3.5xL19mm	ISRO35T19SC2	FDA UDI	Class II	Active
Cervical Drill Revision with Stop L14	GN0096D214	FDA UDI	Class I	Active

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