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 Trial Sizer with stop 16x12, H08mm	RO0334AC0816X12	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD12xH07	ISRO1218L07CA1	FDA UDI	Class II	Active
Romero Lordotic Rasp with Stop 14x16, H09 mm	RO0125LB0914X1	FDA UDI	Class I	Active
ROMERO Self Tapping Screw, D3.5xL16mm	ISRO35T16SC2	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W16xD14xH12	ISRO1416L12CB1	FDA UDI	Class II	Active
Implant Holder with Drill Guides W20 x H10 mm	RO0836I4100	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 14x14, H09mm	RO1015LA0914X14	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 16x12, H11mm	RO1037LC1116X12	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W14xD14xH05	ISRO1414L05CB1	FDA UDI	Class II	Active
Implant Holder with Drill Guides W16 x H12 mm	RO0818I212	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 16x16, H13mm	RO0159LD1316X16	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 16x16, H11mm	RO1057LD1116X16	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 20x12, H11mm	RO0197LG1120X12	FDA UDI	Class I	Active
Anatomic Trial Sizer 16x12, H10mm	RO1236AC1016X12	FDA UDI	Class I	Active
Anatomic Rasp with Stop 16x16, H04mm	RO1850AD0416X16	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD12xH05	ISRO1216A05CA1	FDA UDI	Class II	Active
Anatomic Rasp 16x14, H13mm	RO1649A21316X14	FDA UDI	Class I	Active
Implant Holder with Drill Guides W20 x H07 mm	RO0833I407	FDA UDI	Class I	Active
Lordotic Trial Sizer 20x12, H11mm	RO1497LG1120X12	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD12xH11	ISRO1216L11CA1	FDA UDI	Class II	Active
Anatomic Rasp 14x12, H11mm	RO1607A11114X12	FDA UDI	Class I	Active
Lordotic Trial Sizer 18x14, H11mm	RO1477LF1118X14	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 20x14, H05mm	RO0201LH0520X14	FDA UDI	Class I	Active
Anatomic Trial Sizer 20x12, H08mm	RO1294AG0820X12	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W20xD14xH06	ISRO1420A06CB1	FDA UDI	Class II	Active
Lordotic Trial Sizer 18x16, H09mm	RO1485L30918X16	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W18xD16xH06	ISRO1618A06CB1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD14xH05	ISRO1420L05CA1	FDA UDI	Class II	Active
Romero Lordotic Rasp with Stop 20x12, H06mm	RO0192LG0620X12	FDA UDI	Class I	Active
Anatomic Trial Sizer 18x12, H07mm	RO1263AE0718X12	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 14x16, H04mm	RO0520LB0414X16	FDA UDI	Class I	Active
ROMERO Self Tapping Screw, D4.0xL16mm	ISRO40T16SC2	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W14xD14xH11	ISRO1414L11CB1	FDA UDI	Class II	Active
Anatomic Trial Sizer with stop 16x16, H04mm	RO0350AD0416X16	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 16x12, H04mm	RO0330AC0416X12	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 14x12, H10mm	RO0506L11014X12	FDA UDI	Class I	Active
Anatomic Rasp with Stop 20x12, H06mm	RO1892AG0620X12	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W16xD16xH04	ISRO1616L04CB1	FDA UDI	Class II	Active
Romero Lordotic Rasp with Stop 20x16, H07mm	RO0213LI0720X16	FDA UDI	Class I	Active
Lordotic Trial Sizer 18x14, H10mm	RO1476LF1018X14	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD12xH06	ISRO1216A06CA1	FDA UDI	Class II	Active
Anatomic Trial Sizer 18x16, H04mm	RO1280A30418X16	FDA UDI	Class I	Active
Anatomic Rasp 18x16, H06mm	RO1682A30618X16	FDA UDI	Class I	Active
Anatomic Trial Sizer 14x12, H10mm	RO1206A11014X12	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD16xH06	ISRO1620L06CA1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD16xH11	ISRO1620L11CA1	FDA UDI	Class II	Active
Anatomic Trial Sizer 20x14, H10mm	RO1306AH1020X14	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 14x14, H11mm	RO1017LA1114X14	FDA UDI	Class I	Active
Anatomic Trial Sizer 16x12, H12mm	RO1238AC1216X12	FDA UDI	Class I	Active
Anatomic Rasp with Stop 16x14, H10mm	RO1846A21016X14	FDA UDI	Class I	Active

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