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 20x14, H07mm	RO0403AH0720X14	FDA UDI	Class I	Active
ROMERO Self Drilling Screw, D4.0xL18mm	ISRO40D18SC2	FDA UDI	Class II	Active
Bawl Joint Awl, with Stop	RO0020BJAS	FDA UDI	Class I	Active
Anatomic Rasp 18x16, H13mm	RO1689A31318X16	FDA UDI	Class I	Active
Anatomic Trial Sizer 16x14, H10mm	RO1246A21016X14	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD12xH08	ISRO1220A08CA1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD12xH07	ISRO1220A07CA1	FDA UDI	Class II	Active
Ball Joint Drill with Stop D3.5xL08	RO2100V108	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 14x12, H06 mm	RO0102L10614X12	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 20x16, H05mm	RO0211LI0520X16	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W20xD16xH09	ISRO1620A09CB1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD16xH08	ISRO1618L08CA1	FDA UDI	Class II	Active
Anatomic Rasp 14x12, H05mm	RO1601A10514X12	FDA UDI	Class I	Active
Anatomic Rasp 20x16, H07mm	RO1713AI0720X16	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W16xD12xH09	ISRO1216L09CB1	FDA UDI	Class II	Active
Romero Lordotic Rasp with Stop 14x16, H11 mm	RO0127LB1114X16	FDA UDI	Class I	Active
Anatomic Rasp with Stop 18x14, H09mm	RO1875AF0918X14	FDA UDI	Class I	Active
Implant Holder with Drill Guides W20 x H11 mm	RO0837I411	FDA UDI	Class I	Active
Anatomic Trial Sizer 14x12, H13mm	RO1209A11314X12	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 18x14, H07mm	RO0573LF0718X14	FDA UDI	Class I	Active
ROMERO Self Tapping Screw, D4.0xL18mm	ISRO40T18SC2	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W14xD12xH12	ISRO1214L12CA1	FDA UDI	Class II	Active
Lordotic Trial Sizer 16x12, H11mm	RO1437LC1116X12	FDA UDI	Class I	Active
Anatomic Rasp 14x16, H07mm	RO1623AB0714X16	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 14x14, H07 mm	RO0113LA0714X14	FDA UDI	Class I	Active
Anatomic Rasp with Stop 16x16, H08mm	RO1854AD0816X16	FDA UDI	Class I	Active
Anatomic Rasp with Stop 20x14, H12mm	RO1908AH1220X14	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 16x12, H05mm	RO1031LC0516X12	FDA UDI	Class I	Active
Lordotic Trial Sizer 18x12, H07mm	RO1463LE0718X12	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 16x14, H12mm	RO0348A21216X14	FDA UDI	Class I	Active
Anatomic Rasp 20x12, H05mm	RO1691AG0520X12	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W18xD12xH04	ISRO1218A04CB1	FDA UDI	Class II	Active
Anatomic Trial Sizer with stop 14x14, H10mm	RO0316AA1014X14	FDA UDI	Class I	Active
Lordotic Trial Sizer 18x16, H05mm	RO1481L30518X16	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 16x12, H09mm	RO0535LC0916X12	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 14x12, H10 mm	RO0106L11014X12	FDA UDI	Class I	Active
ROMERO Self Drilling Screw, D3.5xL12mm	ISRO35D12SC2	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD12xH11	ISRO1216A11CA1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W18xD16xH04	ISRO1618L04CB1	FDA UDI	Class II	Active
Anatomic Rasp with Stop 20x16, H04mm	RO1910AI0420X16	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD16xH05	ISRO1618L05CA1	FDA UDI	Class II	Active
Anatomic Rasp with Stop 20x16, H10mm	RO1916AI1020X16	FDA UDI	Class I	Active
Anatomic Rasp with Stop 16x16, H10mm	RO1856AD1016X16	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 16x14, H05mm	RO0541L20516X14	FDA UDI	Class I	Active
Anatomic Trial Sizer 18x14, H11mm	RO1277AF1118X14	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W14xD16xH08	ISRO1614A08CA1	FDA UDI	Class II	Active
Romero Lordotic Rasp with Stop 18x12, H10mm	RO0166LE1018X12	FDA UDI	Class I	Active
Anatomic Trial Sizer 20x14, H09mm	RO1305AH0920X14	FDA UDI	Class I	Active
Lordotic Trial Sizer 16x12, H07mm	RO1433LC0716X12	FDA UDI	Class I	Active
ROMERO Self Drilling Screw, D4.0xL08mm	ISRO40D08SC2	FDA UDI	Class II	Active

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