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 with Stop 16x12, H13mm	RO1839AC1316X12	FDA UDI	Class I	Active
Anatomic Trial Sizer 16x14, H12mm	RO1248A21216X14	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 18x14, H11mm	RO1077LF1118X14	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 20x16, H08mm	RO0614LI0820X16	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W14xD14xH06	ISRO1414L06CB1	FDA UDI	Class II	Active
Cervical Drill Revision with Stop L15	GN0097D215	FDA UDI	Class I	Active
ROMERO Self Tapping Screw, D4.0xL19mm	ISRO40T19SC2	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD12xH13	ISRO1216A13CA1	FDA UDI	Class II	Active
ROMERO Lordotic Rasp 14x12, H07 mm	RO1003L10714X12	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 20x12, H07mm	B806RO1093LG0720X12	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 14x12, H06mm	RO0302A10614X12	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD14xH10	ISRO1418A10CA1	FDA UDI	Class II	Active
Implant Holder with Drill Guides W16 x H08 mm	RO0814I208	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W14xD14xH10	ISRO1414L10CA1	FDA UDI	Class II	Active
ROMERO Lordotic Rasp 16x16, H12mm	RO1058LD1216X16	FDA UDI	Class I	Active
Lordotic Trial Sizer 18x14, H09mm	RO1475LF0918X14	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 16x12, H11mm	RO0337AC1116X12	FDA UDI	Class I	Active
Anatomic Rasp 20x14, H09mm	RO1705AH0920X14	FDA UDI	Class I	Active
Cervical Drill Primary with Stop L14	GN0076D114	FDA UDI	Class I	Active
Anatomic Rasp with Stop 14x16, H10mm	RO1826AB1014X1	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 18x14, H08mm	RO0174LF0818X14	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD16xH08	ISRO1620L08CA1	FDA UDI	Class II	Active
Romero Lordotic Rasp with Stop 16x14, H05 mm	RO0141L20516X14	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD14xH10	ISRO1418L10CA1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W14xD14xH06	ISRO1414A06CB1	FDA UDI	Class II	Active
Lordotic Trial Sizer 14x14, H06mm	RO1412LA0614X14	FDA UDI	Class I	Active
Cervical Drill Primary with Stop L17	GN0079D117	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 16x12, H10mm	RO0536LC1016X12	FDA UDI	Class I	Active
Cervical Drill Primary with Stop L13	GN0075D113	FDA UDI	Class I	Active
Anatomic Rasp 18x12, H10mm	RO1666AE1018X12	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 16x12, H12mm	RO0338AC1216X12	FDA UDI	Class I	Active
Anatomic Trial Sizer 14x12, H07mm	RO1203A10714X12	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD12xH13	ISRO1218A13CA1	FDA UDI	Class II	Active
Anatomic Trial Sizer with stop 20x16, H06mm	RO0412AI0620X16	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W14xD14xH12	ISRO1414L12CB1	FDA UDI	Class II	Active
Lordotic Trial Sizer with Stop 16x12, H13mm	RO0539LC1316X12	FDA UDI	Class I	Active
Romero Large Introducer for Standard Heights	RO0005LISH	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 20x16, H11mm	RO0617LI1120X16	FDA UDI	Class I	Active
Anatomic Trial Sizer 20x12, H06mm	RO1292AG0620X12	FDA UDI	Class I	Active
Implant Holder with Drill Guides W20 x H05 mm	RO0831I405	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 18x12, H11mm	RO0167LE1118X12	FDA UDI	Class I	Active
Lordotic Trial Sizer 20x12, H07mm	RO1493LG0720X12	FDA UDI	Class I	Active
Anatomic Rasp 18x16, H04mm	RO1680A30418X16	FDA UDI	Class I	Active
Free Hand Introducer With Stop for Standard Heights (H < 10)	RO0030FHSS	FDA UDI	Class I	Active
Lordotic Trial Sizer 14x16, H11mm	RO1427LB1114X16	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD12xH08	ISRO1218A08CA1	FDA UDI	Class II	Active
Lordotic Trial Sizer with Stop 18x16, H09mm	RO0585L30918X16	FDA UDI	Class I	Active
Anatomic Trial Sizer 14x12, H05mm	RO1201A10514X12	FDA UDI	Class I	Active
Lordotic Trial Sizer 18x12, H09mm	RO1465LE0918X12	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD16xH08	ISRO1616L08CA1	FDA UDI	Class II	Active

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