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 18x16, H05mm	RO0581L30518X16	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 14x12, H09mm	RO0305A10914X12	FDA UDI	Class I	Active
Implant Holder with Drill Guides W16 x H07 mm	RO0813I207	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 16x16, H11mm	RO0157LD1116X16	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 18x16, H10mm	RO0586L31018X16	FDA UDI	Class I	Active
Anatomic Rasp 16x12, H07mm	RO1633AC0716X12	FDA UDI	Class I	Active
Anatomic Rasp with Stop 14x16, H06mm	RO1822AB0614X16	FDA UDI	Class I	Active
Lordotic Trial Sizer 16x16, H08mm	RO1454LD0816X16	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 20x14, H13mm	RO0609LH1320X14	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 14x16, H13mm	RO0329AB1314X16	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 20x16, H12mm	RO1118LI1220X16	FDA UDI	Class I	Active
Anatomic Trial Sizer 14x16, H10mm	RO1226AB1014X16	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W14xD16xH06	ISRO1614A06CB1	FDA UDI	Class II	Active
Anatomic Rasp 18x14, H06mm	RO1672AF0618X14	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 20x12, H13mm	RO1099LG1320X12	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 14x12, H12mm	RO0308A11214X12	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W18xD14xH11	ISRO1418A11CB1	FDA UDI	Class II	Active
Anatomic Rasp 14x16, H11mm	RO1627AB1114X16	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 18x16, H09mm	RO0385A30918X16	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 20x16, H04mm	RO0610LI0420X16	FDA UDI	Class I	Active
Anatomic Rasp with Stop 16x14, H09mm	RO1845A20916X14	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD14xH05	ISRO1418A05CA1	FDA UDI	Class II	Active
Romero Lordotic Rasp with Stop 16x16, H07mm	RO0153LD0716X16	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 18x12, H06mm	RO0362AE0618X12	FDA UDI	Class I	Active
Anatomic Rasp with Stop 20x12, H12mm	RO1898AG1220X12	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W16xD14xH08	ISRO1416A08CB1	FDA UDI	Class II	Active
Anatomic Trial Sizer 14x12, H12mm	RO1208A11214X12	FDA UDI	Class I	Active
Lordotic Trial Sizer 20x16, H04mm	RO1510LI0420X16	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 16x16, H06mm	RO0152LD0616X16	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD14xH12	ISRO1420A12CA1	FDA UDI	Class II	Active
Quick Connect Awl, With Stop	RO0021QCAS	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 20x16, H10mm	RO0616LI1020X16	FDA UDI	Class I	Active
Cervical Drill Primary with Stop L09	GN0071D109	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD16xH13	ISRO1616A13CA1	FDA UDI	Class II	Active
Anatomic Trial Sizer with stop 14x16, H06mm	RO0322AB0614X16	FDA UDI	Class I	Active
Cervical Tap Primary with Stop L12	GN0054T112	FDA UDI	Class I	Active
Implant Holder with Drill Guides W20 x H13 mm	RO0839I413	FDA UDI	Class I	Active
Romero Introducer Shaft	RO0033ISZZ	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 20x16, H09mm	RO0615LI0920X16	FDA UDI	Class I	Active
Anatomic Rasp 14x14, H12mm	RO1618AA1214X14	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W14xD12xH08	ISRO1214A08CB1	FDA UDI	Class II	Active
ROMERO Self Drilling Screw, D4.0xL14mm	ISRO40D14SC2	FDA UDI	Class II	Active
Anatomic Trial Sizer 14x16, H06mm	RO1222AB0614X16	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD16xH07	ISRO1616L07CA1	FDA UDI	Class II	Active
Lordotic Trial Sizer with Stop 18x14, H09mm	RO0575LF0918X14	FDA UDI	Class I	Active
Lordotic Trial Sizer 18x14, H07mm	RO1473LF0718X14	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 20x12, H11mm	RO0397AG1120X12	FDA UDI	Class I	Active
ROMERO Self Drilling Screw, D4.0xL19mm	ISRO40D19SC2	FDA UDI	Class II	Active
Lordotic Trial Sizer with Stop 18x12, H07mm	RO0563LE0718X12	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 14x12, H12mm	RO0508L11214X12	FDA UDI	Class I	Active

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