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
Angled Awl, With Stop	RO0019AASZ	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 14x12, H08mm	RO0504L10814X12	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD14xH06	ISRO1418A06CA1	FDA UDI	Class II	Active
ROMERO Lordotic Rasp 16x16, H07mm	RO1053LD0716X16	FDA UDI	Class I	Active
Anatomic Rasp 20x12, H04mm	RO1690AG0420X12	FDA UDI	Class I	Active
ROMERO Self Tapping Screw, D4.0xL20mm	ISRO40T20SC2	FDA UDI	Class II	Active
Small Slotted Mallet	GN0001SSMZ	FDA UDI	Class I	Active
Anatomic Rasp 20x16, H06mm	RO1712AI0620X16	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD12xH06	ISRO1216L06CA1	FDA UDI	Class II	Active
Cervical Drill Revision with Stop L09	GN0091D209	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W20xD12xH07	ISRO1220L07CB1	FDA UDI	Class II	Active
Lordotic Trial Sizer with Stop 16x14, H13mm	RO0549L21316X14	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W14xD12xH10	ISRO1214L10CB1	FDA UDI	Class II	Active
Romero Lordotic Rasp with Stop 18x16, H06mm	RO0182L30618X16	FDA UDI	Class I	Active
Implant Holder with Drill Guides W14 x H12 mm	RO0808I112	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W20xD14xH13	ISRO1420A13CB1	FDA UDI	Class II	Active
Anatomic Rasp with Stop 16x12, H06mm	RO1832AC0616X12	FDA UDI	Class I	Active
Ball Joint Drill with Stop D3.5xL08	RO2000F1080	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W16xD16xH11	ISRO1616L11CB1	FDA UDI	Class II	Active
Anatomic Trial Sizer 16x16, H11mm	RO1257AD1116X16	FDA UDI	Class I	Active
Anatomic Rasp with Stop 14x14, H05mm	RO1811AA0514X14	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 20x12, H07mm	RO0193LG0720X12	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 18x14, H12mm	RO0578LF1218X14	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 18x14, H10mm	RO0576LF1018X14	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 18x14, H10mm	RO0176LF1018X14	FDA UDI	Class I	Active
Anatomic Rasp with Stop 16x16, H09mm	RO1855AD0916X16	FDA UDI	Class I	Active
Anatomic Trial Sizer 20x12, H10mm	RO1296AG1020X12	FDA UDI	Class I	Active
Anatomic Trial Sizer 14x14, H07mm	RO1213AA0714X14	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 14x16, H07mm	RO1023LB0714X16	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 16x16, H10mm	RO0156LD1016X16	FDA UDI	Class I	Active
Anatomic Rasp with Stop 14x16, H05mm	RO1821AB0514X16	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 14x16, H10mm	RO0526LB1014X16	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 16x14, H08mm	RO0344A20816X14	FDA UDI	Class I	Active
Anatomic Rasp 18x16, H05mm	RO1681A30518X16	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 20x12, H09mm	RO0195LG0920X12	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 16x16, H12mm	RO0558LD1216X16	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 14x16, H06mm	RO0522LB0614X16	FDA UDI	Class I	Active
Anatomic Rasp 18x12, H07mm	RO1663AE0718X12	FDA UDI	Class I	Active
Anatomic Rasp 20x14, H13mm	RO1709AH1320X14	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD14xH12	ISRO1418L12CA1	FDA UDI	Class II	Active
Anatomic Trial Sizer 18x12, H08mm	RO1264AE0818X12	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 18x12, H06mm	RO0562LE0618X12	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W18xD16xH11	ISRO1618A11CB1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W14xD14xH10	ISRO1414A10CB1	FDA UDI	Class II	Active
Lordotic Trial Sizer 18x14, H04mm	RO1470LF0418X14	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W16xD14xH09	ISRO1416A09CB1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD12xH11	ISRO1220A11CA1	FDA UDI	Class II	Active
Lordotic Trial Sizer with Stop 16x16, H13mm	RO0559LD1316X16	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W20xD12xH04	ISRO1220L04CB1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD16xH04	ISRO1618A04CA1	FDA UDI	Class II	Active

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