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 18x16, H07mm	RO1483L30718X16	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD16xH05	ISRO1620L05CA1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W14xD12xH06	ISRO1214A06CB1	FDA UDI	Class II	Active
Anatomic Rasp 16x16, H06mm	RO1652AD0616X16	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD14xH08	ISRO1420L08CA1	FDA UDI	Class II	Active
Implant Holder with Drill Guides W14 x H06 mm	RO0802I106	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W16xD16xH09	ISRO1616L09CB1	FDA UDI	Class II	Active
ROMERO Lordotic Rasp 16x14, H06mm	RO1042L20616X14	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W16xD16xH13	ISRO1616L13CB1	FDA UDI	Class II	Active
ROMERO Lordotic Rasp 20x12, H06mm	RO1092LG0620X12	FDA UDI	Class I	Active
Anatomic Rasp 18x12, H12mm	RO1668AE1218X12	FDA UDI	Class I	Active
Anatomic Rasp 14x14, H05mm	RO1611AA0514X14	FDA UDI	Class I	Active
Lordotic Trial Sizer 20x14, H07mm	RO1503LH0720X14	FDA UDI	Class I	Active
Anatomic Rasp with Stop 18x16, H10mm	RO1886A31018X16	FDA UDI	Class I	Active
Anatomic Rasp 18x12, H13mm	RO1669AE1318X12	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD16xH04	ISRO1616A04CA1	FDA UDI	Class II	Active
Romero Cervical Screw Driver Shaft Ball Joint Quick Connect - 15mm	RO0036SDBJ	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 20x16, H11mm	RO0417AI1120X16	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 16x14, H04mm	RO1040L20416X14	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 18x14, H08mm	RO0374AF0818X14	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W14xD14xH06	ISRO1414A06CA1	FDA UDI	Class II	Active
Anatomic Rasp with Stop 16x12, H04mm	RO1830AC0416X12	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD14xH12	ISRO1420L12CA1	FDA UDI	Class II	Active
Anatomic Rasp with Stop 14x12, H05mm	RO1801AI0514X12	FDA UDI	Class I	Active
Cervical Screw Driver Shaft Straight Quick Connect	GN0011T08S	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 18x12, H08mm	RO0564LE0818X12	FDA UDI	Class I	Active
Lordotic Trial Sizer 18x14, H05mm	RO1471LF0518X14	FDA UDI	Class I	Active
Anatomic Trial Sizer 18x16, H13mm	RO1289A31318X16	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W20xD16xH04	ISRO1620L04CB1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W14xD14xH09	ISRO1414L09CA1	FDA UDI	Class II	Active
Anatomic Rasp 14x12, H12mm	RO1608A11214X12	FDA UDI	Class I	Active
Anatomic Rasp with Stop 18x14, H06mm	RO1872AF0618X14	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 16x16, H08mm	RO0354AD0816X16	FDA UDI	Class I	Active
Anatomic Rasp with Stop 18x14, H13mm	RO1879AF1318X14	FDA UDI	Class I	Active
Lordotic Trial Sizer 20x16, H13mm	RO1519LI1320X16	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 14x16, H05mm	RO1021LB0514X16	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 14x12, H07 mm	RO0103L10714X12	FDA UDI	Class I	Active
Anatomic Rasp with Stop 18x14, H04mm	RO1870AF0418X14	FDA UDI	Class I	Active
Anatomic Rasp 14x16, H10mm	RO1626AB1014X16	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W18xD12xH05	ISRO1218L05CB1	FDA UDI	Class II	Active
Anatomic Trial Sizer with stop 20x16, H10mm	RO0416AI1020X16	FDA UDI	Class I	Active
Implant Holder with Drill Guides W18 x H12 mm	RO0828I312	FDA UDI	Class I	Active
Anatomic Rasp 18x14, H10mm	RO1676AF1018X14	FDA UDI	Class I	Active
Basic Instrument Sterilization Container	RO0902BIC1	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W18xD14xH12	ISRO1418L12CB1	FDA UDI	Class II	Active
Anatomic Trial Sizer 20x14, H12mm	RO1308AH1220X14	FDA UDI	Class I	Active
Anatomic Rasp 14x16, H06mm	RO1622AB0614X16	FDA UDI	Class I	Active
Anatomic Trial Sizer 18x16, H12mm	RO1288A31218X16	FDA UDI	Class I	Active
Anatomic Rasp 14x16, H13mm	RO1629AB1314X16	FDA UDI	Class I	Active
ROMERO Self Drilling Screw, D3.5xL10mm	ISRO35D10SC2	FDA UDI	Class II	Active

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