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 14x14, H13mm	RO1819AA1314X14	FDA UDI	Class I	Active
ROMERO Self Tapping Screw, D3.5xL10mm	ISRO35T10SC2	FDA UDI	Class II	Active
Anatomic Trial Sizer with stop 20x16, H05mm	RO0411AI0520X16	FDA UDI	Class I	Active
Medium AO Quick Connect Handle	GN0005MAQC	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W20xD14xH10	ISRO1420A10CB1	FDA UDI	Class II	Active
Anatomic Rasp with Stop 20x14, H10mm	RO1906AH1020X14	FDA UDI	Class I	Active
Anatomic Trial Sizer 18x14, H06mm	RO1272AF0618X14	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W14xD12xH05	ISRO1214A05CB1	FDA UDI	Class II	Active
Anatomic Trial Sizer 14x14, H12mm	RO1218AA1214X14	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W20xD12xH13	ISRO1220L13CB1	FDA UDI	Class II	Active
Lordotic Trial Sizer with Stop 20x16, H13mm	RO0619LI1320X16	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD12xH10	ISRO1220L10CA1	FDA UDI	Class II	Active
ROMERO Lordotic Rasp 18x16, H09mm	RO1085L30918X16	FDA UDI	Class I	Active
Anatomic Trial Sizer 18x14, H12mm	RO1278AF1218X14	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W14xD12xH12	ISRO1214A12CA1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W14xD16xH11	ISRO1614A11CA1	FDA UDI	Class II	Active
Anatomic Rasp with Stop 16x12, H07mm	RO1833AC0716X12	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 16x12, H12mm	RO0538LC1216X12	FDA UDI	Class I	Active
Lordotic Trial Sizer 14x12, H11mm	RO1407L11114X12	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W14xD16xH09	ISRO1614A09CB1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD12xH13	ISRO1220L13CA1	FDA UDI	Class II	Active
Romero Lordotic Rasp with Stop 14x14, H10 mm	RO0116LA1014X14	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W20xD14xH11	ISRO1420A11CB1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W14xD12xH11	ISRO1214A11CA1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W18xD12xH12	ISRO1218L12CB1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD14xH13	ISRO1420L13CA1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD12xH13	ISRO1220A13CA1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W18xD14xH07	ISRO1418A07CB1	FDA UDI	Class II	Active
Lordotic Trial Sizer with Stop 16x16, H09mm	RO0555LD0916X16	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 20x12, H05mm	RO1091LG0520X12	FDA UDI	Class I	Active
Anatomic Trial Sizer 20x14, H04mm	RO1300AH0420X14	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W18xD12xH09	ISRO1218L09CB1	FDA UDI	Class II	Active
ROMERO Lordotic Rasp 18x12, H13mm	RO1069LE1318X12	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 20x16, H07mm	RO0413AI0720X16	FDA UDI	Class I	Active
Lordotic Trial Sizer 14x14, H08mm	RO1414LA0814X14	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD14xH04	ISRO1418A04CA1	FDA UDI	Class II	Active
Anatomic Rasp with Stop 20x12, H10mm	RO1896AG1020X12	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 14x16, H12mm	RO1028LB1214X16	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 16x16, H13mm	RO0359AD1316X16	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W18xD16xH08	ISRO1618A08CB1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD14xH06	ISRO1420A06CA1	FDA UDI	Class II	Active
Anatomic Rasp with Stop 14x16, H12mm	RO1828AB1214X16	FDA UDI	Class I	Active
Lordotic Trial Sizer 18x12, H13mm	RO1469LE1318X12	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 18x14, H06mm	RO0372AF0618X14	FDA UDI	Class I	Active
Cervical Drill Revision with Stop L20	GN0102D220	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W14xD12xH10	ISRO1214A10CB1	FDA UDI	Class II	Active
Cervical Drill Revision with Stop L08	GN0090D208	FDA UDI	Class I	Active
Anatomic Trial Sizer 18x12, H10mm	RO1266AE1018X12	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W20xD12xH10	ISRO1220A10CB1	FDA UDI	Class II	Active
Lordotic Trial Sizer with Stop 14x14, H13mm	RO0519LA1314X14	FDA UDI	Class I	Active

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