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 14x16, H05mm	RO1421LB0514X16	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 14x16, H06 mm	RO0122LB0614X16	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD16xH12	ISRO1616A12CA1	FDA UDI	Class II	Active
Lordotic Trial Sizer with Stop 14x16, H12mm	RO0528LB1214X16	FDA UDI	Class I	Active
Lordotic Trial Sizer 16x12, H05mm	RO1431LC0516X12	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 18x12, H06mm	RO1062LE0618X12	FDA UDI	Class I	Active
Anatomic Trial Sizer 20x12, H12mm	RO1298AG1220X12	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W20xD14xH09	ISRO1420A09CB1	FDA UDI	Class II	Active
Anatomic Trial Sizer 18x12, H09mm	RO1265AE0918X12	FDA UDI	Class I	Active
Anatomic Trial Sizer 20x14, H11mm	RO1307AH1120X14	FDA UDI	Class I	Active
Anatomic Trial Sizer 20x12, H11mm	RO1297AG1120X12	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 20x14, H07mm	RO0203LH0720X14	FDA UDI	Class I	Active
Anatomic Rasp with Stop 16x12, H10mm	RO1836AC1016X12	FDA UDI	Class I	Active
ROMERO Self Tapping Screw, D4.0xL15mm	ISRO40T15SC2	FDA UDI	Class II	Active
Anatomic Rasp with Stop 18x12, H04mm	RO1860AE0418X12	FDA UDI	Class I	Active
Anatomic Rasp with Stop 14x16, H08mm	RO1824AB0814X16	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 16x14, H10mm	RO0346A21016X14	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W16xD12xH11	ISRO1216L11CB1	FDA UDI	Class II	Active
Anatomic Rasp 18x12, H09mm	RO1665AE0918X12	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD14xH09	ISRO1418A09CA1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W18xD16xH08	ISRO1618L08CB1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W20xD12xH08	ISRO1220A08CB1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W18xD16xH04	ISRO1618A04CB1	FDA UDI	Class II	Active
Lordotic Trial Sizer 14x16, H09mm	RO1425LB0914X160	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W14xD12xH13	ISRO1214A13CA1	FDA UDI	Class II	Active
Anatomic Trial Sizer 20x12, H07mm	RO1293AG0720X12	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 14x16, H09mm	RO0525LB0914X16	FDA UDI	Class I	Active
Anatomic Trial Sizer 20x16, H12mm	RO1318AI1220X16	FDA UDI	Class I	Active
Cervical Drill Primary with Stop L22	GN0084D122	FDA UDI	Class I	Active
ROMERO Self Drilling Screw, D3.5xL19mm	ISRO35D19SC2	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W18xD12xH11	ISRO1218L11CB1	FDA UDI	Class II	Active
Lordotic Trial Sizer with Stop 16x12, H06mm	RO0532LC0616X12	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 18x14, H05mm	RO0371AF0518X14	FDA UDI	Class I	Active
Lordotic Trial Sizer 16x16, H05mm	RO1451LD0516X16	FDA UDI	Class I	Active
ROMERO Self Tapping Screw, D4.0xL10mm	ISRO40T10SC2	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W18xD14xH05	ISRO1418A05CB1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD12xH04	ISRO1220A04CA1	FDA UDI	Class II	Active
Anatomic Trial Sizer with stop 14x16, H10mm	RO0326AB1014X16	FDA UDI	Class I	Active
Anatomic Rasp with Stop 20x16, H13mm	RO1919AI1320X16	FDA UDI	Class I	Active
Lordotic Trial Sizer 14x14, H07mm	RO1413LA0714X14	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 16x16, H10mm	RO0356AD1016X16	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD12xH09	ISRO1220L09CA1	FDA UDI	Class II	Active
Ball Joint Drill with Stop D3.5xL15	RO2107V115	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 18x14, H11mm	RO0577LF1118X14	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 16x14, H09 mm	RO0145L20916X14	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD16xH04	ISRO1616L04CA1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W20xD16xH09	ISRO1620L09CB1	FDA UDI	Class II	Active
Anatomic Rasp with Stop 20x12, H13mm	RO1899AG1320X12	FDA UDI	Class I	Active
Anatomic Rasp with Stop 20x14, H11mm	RO1907AH1120X14	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W16xD12xH10	ISRO1216A10CB1	FDA UDI	Class II	Active

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