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 with Stop 16x14, H06mm	RO0542L20616X14	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 16x14, H07mm	RO0543L20716X14	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 18x12, H06mm	RO0162LE0618X12	FDA UDI	Class I	Active
Lordotic Trial Sizer 18x16, H10mm	RO1486L31018X16	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD16xH10	ISRO1616L10CA1	FDA UDI	Class II	Active
Anatomic Trial Sizer 18x12, H12mm	RO1268AE1218X12	FDA UDI	Class I	Active
Ball Joint Drill with Stop D3.5xL18	RO2010F118	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W20xD14xH04	ISRO1420L04CB1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD14xH10	ISRO1420A10CA1	FDA UDI	Class II	Active
Lordotic Trial Sizer with Stop 20x16, H12mm	RO0618LI1220X16	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 14x16, H07mm	RO0323AB0714X16	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 18x14, H05mm	RO1071LF0518X14	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W16xD16xH04	ISRO1616A04CB1	FDA UDI	Class II	Active
Anatomic Trial Sizer with stop 18x14, H07mm	RO0373AF0718X14	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 20x14, H08mm	RO0404AH0820X14	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD16xH10	ISRO1620A10CA1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W20xD14xH07	ISRO1420L07CB1	FDA UDI	Class II	Active
Anatomic Trial Sizer with stop 14x14, H13mm	RO0319AA1314X14	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 18x12, H11mm	RO1067LE1118X12	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 14x14, H12mm	RO1018LA1214X14	FDA UDI	Class I	Active
Anatomic Rasp 18x14, H04mm	RO1670AF0418X14	FDA UDI	Class I	Active
ROMERO Self Drilling Screw, D4.0xL09mm	ISRO40D09SC2	FDA UDI	Class II	Active
Ball Joint Drill with Stop D3.5xL11	RO2003F111	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 20x12, H08mm	RO0594LG0820X12	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 18x16, H12mm	RO0588L31218X16	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 18x12, H10mm	RO0366AE1018X12	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 18x14, H13mm	RO1079LF1318X14	FDA UDI	Class I	Active
Anatomic Trial Sizer 14x12, H06mm	RO1202A10614X12	FDA UDI	Class I	Active
Ball Joint Drill with Stop D3.5xL13	RO2105V113	FDA UDI	Class I	Active
Ball Joint Drill with Stop D3.5xL17	RO2009F117	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W16xD12xH06	ISRO1216L06CB1	FDA UDI	Class II	Active
Lordotic Trial Sizer 16x12, H13mm	RO1439LC1316X12	FDA UDI	Class I	Active
Lordotic Trial Sizer 20x12, H09mm	RO1495LG0920X1	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W20xD16xH07	ISRO1620L07CB1	FDA UDI	Class II	Active
Romero Lordotic Rasp with Stop 18x12, H07mm	RO0163LE0718X12	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W16xD14xH11	ISRO1416L11CB1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W20xD16xH11	ISRO1620A11CB1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W14xD14xH12	ISRO1414L12CA1	FDA UDI	Class II	Active
Lordotic Trial Sizer 20x14, H09mm	RO1505LH0920X14	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 14x14, H08 mm	RO0114LA0814X14	FDA UDI	Class I	Active
Quick Connect Ball Joint Awl	RO0037QBJA	FDA UDI	Class I	Active
Cervical Tap Primary with Stop L09	GN0051T109	FDA UDI	Class I	Active
Anatomic Trial Sizer 14x16, H13mm	RO1229AB1314X16	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W14xD16xH04	ISRO1614L04CB1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W14xD14xH11	ISRO1414A11CB1	FDA UDI	Class II	Active
Cervical Drill Revision with Stop L18	GN0100D218	FDA UDI	Class I	Active
Lordotic Trial Sizer 20x12, H13mm	RO1499LG1320X12	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W14xD14xH13	ISRO1414A13CA1	FDA UDI	Class II	Active
ROMERO Lordotic Rasp 14x14, H08mm	RO1014LA0814X14	FDA UDI	Class I	Active
ROMERO Self Drilling Screw, D4.0xL11mm	ISRO40D11SC2	FDA UDI	Class II	Active

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