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 14x14, H09mm	RO0515LA0914X14	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD12xH04	ISRO1218A04CA1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W14xD12xH07	ISRO1214A07CB1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD12xH10	ISRO1218A10CA1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD16xH13	ISRO1620A13CA1	FDA UDI	Class II	Active
Lordotic Trial Sizer with Stop 14x14, H11mm	RO0517LA1114X14	FDA UDI	Class I	Active
Anatomic Rasp 16x12, H08mm	RO1634AC0816X12	FDA UDI	Class I	Active
Anatomic Rasp with Stop 18x12, H13mm	RO1869AE1318X12	FDA UDI	Class I	Active
Implant Holder with Drill Guides W14 x H11 mm	RO0807I111	FDA UDI	Class I	Active
Anatomic Rasp 20x14, H06mm	RO1702AH0620X14	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W14xD14xH07	ISRO1414A07CB1	FDA UDI	Class II	Active
Anatomic Rasp 14x14, H11mm	RO1617AA1114X14	FDA UDI	Class I	Active
Implant Holder with Drill Guides W18 x H11 mm	RO0827I311	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD12xH07	ISRO1216L07CA1	FDA UDI	Class II	Active
Anatomic Rasp with Stop 20x12, H08mm	RO1894AG0820X12	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 20x12, H11mm	RO1107LH1120X14	FDA UDI	Class I	Active
Lordotic Trial Sizer 16x16, H13mm	RO1459LD1316X16	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W14xD12xH12	ISRO1214L12CB1	FDA UDI	Class II	Active
Anatomic Rasp with Stop 18x14, H12mm	RO1878AF1218X14	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W20xD12xH09	ISRO1220L09CB1	FDA UDI	Class II	Active
Lordotic Trial Sizer 20x16, H06mm	RO1512LI0620X16	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W14xD16xH13	ISRO1614L13CB1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W14xD16xH12	ISRO1614L12CA1	FDA UDI	Class II	Active
ROMERO Lordotic Rasp 14x14, H05 mm	RO1011LA0514X14	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD16xH05	ISRO1616A05CA1	FDA UDI	Class II	Active
Anatomic Rasp with Stop 14x16, H09mm	RO1825AB0914X16	FDA UDI	Class I	Active
Lordotic Trial Sizer 14x14, H05mm	RO1411LA0514X14	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W20xD12xH11	ISRO1220A11CB1	FDA UDI	Class II	Active
Romero Lordotic Rasp with Stop 20x14, H13mm	RO0209LH1320X14	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 16x16, H06mm	RO0552LD0616X16	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W14xD16xH05	ISRO1614A05CB1	FDA UDI	Class II	Active
Lordotic Trial Sizer with Stop 20x14, H05mm	RO0601LH0520X14	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W14xD14xH11	ISRO1414A11CA1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W20xD12xH11	ISRO1220L11CB1	FDA UDI	Class II	Active
Anatomic Trial Sizer with stop 14x14, H05mm	RO0311AA0514X14	FDA UDI	Class I	Active
Anatomic Rasp 16x16, H12mm	RO1658AD1216X16	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W14xD14xH08	ISRO1414L08CB1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W18xD12xH11	ISRO1218A11CB1	FDA UDI	Class II	Active
Anatomic Trial Sizer with stop 14x16, H09mm	RO0325AB0914X16	FDA UDI	Class I	Active
Anatomic Rasp with Stop 18x16, H08mm	RO1884A30818X16	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD16xH10	ISRO1618A10CA1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W14xD12xH05	ISRO1214L05CB1	FDA UDI	Class II	Active
Lordotic Trial Sizer 14x14, H13mm	RO1419LA1314X14	FDA UDI	Class I	Active
Ball Joint Drill with Stop D3.5xL15	RO2007F115	FDA UDI	Class I	Active
Anatomic Rasp with Stop 18x12, H09mm	RO1865AE0918X12	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W16xD16xH12	ISRO1616L12CB1	FDA UDI	Class II	Active
Anatomic Trial Sizer 16x16, H13mm	RO1259AD1316X16	FDA UDI	Class I	Active
Anatomic Rasp with Stop 16x14, H07mm	RO1843A20716X14	FDA UDI	Class I	Active
Anatomic Rasp 20x12, H09mm	RO1695AG0920X12	FDA UDI	Class I	Active
Anatomic Trial Sizer 16x16, H12mm	RO1258AD1216X16	FDA UDI	Class I	Active

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