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
Implant Holder with Drill Guides W18 x H06 mm	RO0822I306	FDA UDI	Class I	Active
Implant Holder with Drill Guides W14 x H08 mm	RO0804I108	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 18x14, H09mm	RO0375AF0918X14	FDA UDI	Class I	Active
Anatomic Trial Sizer 20x12, H04mm	RO1290AG0420X12	FDA UDI	Class I	Active
Anatomic Rasp with Stop 18x16, H13mm	RO1889A31318X16	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 18x14, H08mm	RO1074LF0818X14	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 18x16, H04mm	RO1080L30418X16	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 14x12, H11 mm	RO0107L11114X12	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 14x14, H04 mm	RO0110LA0414X14	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD12xH04	ISRO1216A04CA1	FDA UDI	Class II	Active
Anatomic Trial Sizer with stop 14x14, H12mm	RO0318AA1214X14	FDA UDI	Class I	Active
Anatomic Rasp with Stop 14x14, H11mm	RO1817AA1114X14	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 18x14, H04mm	RO0370AF0418X14	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD16xH11	ISRO1616L11CA1	FDA UDI	Class II	Active
Anatomic Trial Sizer 18x14, H08mm	RO1274AF0818X14	FDA UDI	Class I	Active
Anatomic Rasp with Stop 16x16, H06mm	RO1852AD0616X16	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 14x14, H07mm	RO1013LA0714X14	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 18x14, H06mm	RO0572LF0618X14	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 14x12, H04 mm	RO0100L10414X12	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 18x16, H05mm	RO0181L30518X16	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD16xH08	ISRO1620A08CA1	FDA UDI	Class II	Active
Lordotic Trial Sizer with Stop 20x14, H07mm	RO0603LH0720X14	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 14x12, H11mm	RO0307A11114X12	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 18x16, H13mm	RO1089L31318X16	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD12xH08	ISRO1216A08CA1	FDA UDI	Class II	Active
ROMERO Lordotic Rasp 14x14, H10mm	RO1016LA1014X14	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W20xD16xH11	ISRO1620L11CB1	FDA UDI	Class II	Active
Anatomic Rasp with Stop 18x12, H08mm	RO1864AE0818X12	FDA UDI	Class I	Active
Ball Joint Drill with Stop D3.5xL20	RO2012F120	FDA UDI	Class I	Active
ROMERO Self Drilling Screw, D4.0xL13mm	ISRO40D13SC2	FDA UDI	Class II	Active
Romero Lordotic Rasp with Stop 18x14, H05mm	RO0171LF0518X14	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W16xD14xH08	ISRO1416L08CB1	FDA UDI	Class II	Active
ROMERO Self Drilling Screw, D4.0xL10mm	ISRO40D10SC2	FDA UDI	Class II	Active
Anatomic Rasp 16x16, H13mm	RO1659AD1316X16	FDA UDI	Class I	Active
Anatomic Rasp 18x14, H05mm	RO1671AF0518X14	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 14x14, H06 mm	RO1012LA0614X14	FDA UDI	Class I	Active
Anatomic Rasp with Stop 14x12, H12mm	RO1808AI1214X12	FDA UDI	Class I	Active
Anatomic Rasp with Stop 14x12, H11mm	RO1807AI1114X12	FDA UDI	Class I	Active
ROMERO Self Tapping Screw, D4.0xL17mm	ISRO40T17SC2	FDA UDI	Class II	Active
Ball Joint Drill with Stop D3.5xL12	RO2004F112	FDA UDI	Class I	Active
Small AO Quick Connect Handle	GN0004SAQC	FDA UDI	Class I	Active
Anatomic Trial Sizer 20x16, H10mm	RO1316AI1020X16	FDA UDI	Class I	Active
Anatomic Trial Sizer 14x14, H06mm	RO1212AA0614X14	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W14xD14xH13	ISRO1414A13CB1	FDA UDI	Class II	Active
Anatomic Rasp with Stop 14x12, H08mm	RO1804AI0814X12	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 20x12, H08mm	RO1094LG0820X12	FDA UDI	Class I	Active
Anatomic Rasp with Stop 18x14, H11mm	RO1877AF1118X14	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 18x16, H12mm	RO0388A31218X16	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 14x16, H04mm	RO1020LB0414X16	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD14xH11	ISRO1418A11CA1	FDA UDI	Class II	Active

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