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 20x12, H13mm	RO0599LG1320X12	FDA UDI	Class I	Active
Anatomic Rasp 18x16, H11mm	RO1687A31118X16	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 18x12, H05mm	RO1061LE0518X12	FDA UDI	Class I	Active
Anatomic Trial Sizer 16x12, H09mm	RO1235AC0916X12	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 16x14, H12mm	RO1048L21216X14	FDA UDI	Class I	Active
Anatomic Trial Sizer 14x12, H11mm	RO1207A11114X12	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 18x14, H05mm	B806RO0571LF0518X14	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 18x12, H04mm	RO1060LE0418X12	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 14x16, H12 mm	RO0128LB1214X16	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 16x12, H05mm	RO0531LC0516X12	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 16x14, H07mm	RO0343A20716X14	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD12xH10	ISRO1218L10CA1	FDA UDI	Class II	Active
Cervical Tap Primary with Stop L16	GN0058T116	FDA UDI	Class I	Active
Anatomic Trial Sizer 14x16, H11mm	RO1227AB1114X16	FDA UDI	Class I	Active
ROMERO Self Drilling Screw, D4.0xL16mm	ISRO40D16SC2	FDA UDI	Class II	Active
Anatomic Trial Sizer with stop 20x16, H13mm	RO0419AI1320X16	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 20x12, H10mm	RO1096LG1020X12	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W20xD14xH06	ISRO1420L06CB1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W20xD12xH13	ISRO1220A13CB1	FDA UDI	Class II	Active
Ball Joint Drill with Stop D3.5xL19	RO2011F119	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 18x12, H07mm	RO1063LE0718X12	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W14xD12xH10	ISRO1214A10CA1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W18xD14xH04	ISRO1418A04CB1	FDA UDI	Class II	Active
Anatomic Rasp with Stop 18x12, H10mm	RO1866AE1018X12	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 16x16, H04mm	RO0550LD0416X16	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W16xD14xH07	ISRO1416L07CB1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W18xD12xH13	ISRO1218L13CB1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD14xH09	ISRO1418L09CA1	FDA UDI	Class II	Active
Romero Lordotic Rasp with Stop 18x14, H13mm	RO0179LF1318X14	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 16x12, H13mm	RO1039LC1316X12	FDA UDI	Class I	Active
ROMERO Self Drilling Screw, D3.5xL17mm	ISRO35D17SC2	FDA UDI	Class II	Active
Anatomic Trial Sizer with stop 18x12, H05mm	RO0361AE0518X12	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W14xD12xH08	ISRO1214L08CB1	FDA UDI	Class II	Active
Lordotic Trial Sizer with Stop 20x14, H09mm	RO0605LH0920X14	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD12xH09	ISRO1218L09CA1	FDA UDI	Class II	Active
Lordotic Trial Sizer with Stop 20x12, H09mm	RO0595LG0920X12	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD14xH13	ISRO1420A13CA1	FDA UDI	Class II	Active
Lordotic Trial Sizer with Stop 14x16, H13mm	RO0529LB1314X16	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 14x14, H09 mm	RO0115LA0914X14	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 18x12, H13mm	RO0369AE1318X12	FDA UDI	Class I	Active
Bawl Joint Awl	RO0014BJAZ	FDA UDI	Class I	Active
Lordotic Trial Sizer 18x12, H06mm	RO1462LE0618X12	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 20x14, H11mm	RO0607LH1120X14	FDA UDI	Class I	Active
Anatomic Trial Sizer 16x14, H09mm	RO1245A20916X14	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 14x14, H04mm	RO0510LA0414X14	FDA UDI	Class I	Active
Anatomic Rasp with Stop 20x16, H12mm	RO1918AI1220X16	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 18x16, H13mm	RO0189L31318X16	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 18x14, H13mm	RO0579LF1318X14	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD14xH07	ISRO1420L07CA1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W16xD12xH10	ISRO1216L10CB1	FDA UDI	Class II	Active

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