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 Rasp with Stop 14x12, H07mm	RO1803AI0714X12	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD12xH05	ISRO1218L05CA1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W18xD16xH07	ISRO1618L07CB1	FDA UDI	Class II	Active
Cervical Drill Revision with Stop L12	GN0094D212	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W20xD12xH08	ISRO1220L08CB1	FDA UDI	Class II	Active
Lordotic Trial Sizer with Stop 14x12, H11mm	RO0507L11114X12	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 16x16, H04mm	RO1050LD0416X16	FDA UDI	Class I	Active
ROMERO Self Tapping Screw, D4.0xL13mm	ISRO40T13SC2	FDA UDI	Class II	Active
ROMERO Lordotic Rasp 18x16, H10mm	RO1086L31018X16	FDA UDI	Class I	Active
Anatomic Rasp 16x14, H07mm	RO1643A20716X14	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD16xH11	ISRO1618L11CA1	FDA UDI	Class II	Active
Anatomic Rasp with Stop 14x16, H11mm	RO1827AB1114X16	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD12xH09	ISRO1218A09CA1	FDA UDI	Class II	Active
ROMERO Self Tapping Screw, D3.5xL15mm	ISRO35T15SC2	FDA UDI	Class II	Active
Implant Holder with Drill Guides W14 x H04 mm	RO0800I104	FDA UDI	Class I	Active
Anatomic Rasp with Stop 20x14, H09mm	RO1905AH0920X14	FDA UDI	Class I	Active
Lordotic Trial Sizer 14x14, H12mm	RO1418LA1214X14	FDA UDI	Class I	Active
Anatomic Rasp 20x16, H04mm	RO1710AI0420X16	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W20xD14xH11	ISRO1420L11CB1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W14xD12xH11	ISRO1214L11CA1	FDA UDI	Class II	Active
Anatomic Trial Sizer 18x12, H13mm	RO1269AE1318X12	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W14xD16xH13	ISRO1614L13CA1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W18xD14xH10	ISRO1418L10CB1	FDA UDI	Class II	Active
Implant Holder with Drill Guides W18 x H09 mm	RO0825I309	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W14xD16xH11	ISRO1614L11CA1	FDA UDI	Class II	Active
Lordotic Trial Sizer 16x14, H12mm	RO1448L21216X14	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 14x12, H09 mm	RO0105L10914X12	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 18x16, H06mm	RO0582L30618X16	FDA UDI	Class I	Active
Lordotic Trial Sizer 16x16, H06mm	RO1452LD0616X16	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 20x14, H10mm	RO0206LH1020X14	FDA UDI	Class I	Active
Implant Holder with Drill Guides W14 x H09 mm	RO0805I109	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W14xD16xH09	ISRO1614L09CB1	FDA UDI	Class II	Active
Anatomic Trial Sizer 14x14, H04mm	RO1210AA0414X14	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W20xD12xH12	ISRO1220A12CB1	FDA UDI	Class II	Active
Cervical Tap Primary with Stop L14	GN0056T114	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 18x16, H10mm	RO0386A31018X16	FDA UDI	Class I	Active
Anatomic Trial Sizer 16x16, H07mm	RO1253AD0716X16	FDA UDI	Class I	Active
Implant Holder with Drill Guides W18 x H10 mm	RO0826I310	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W14xD12xH11	ISRO1214A11CB1	FDA UDI	Class II	Active
Anatomic Trial Sizer with stop 20x12, H05mm	RO0391AG0520X12	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD14xH06	ISRO1418L06CA1	FDA UDI	Class II	Active
Lordotic Trial Sizer with Stop 18x12, H11mm	RO0567LE1118X12	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W18xD16xH11	ISRO1618L11CB1	FDA UDI	Class II	Active
Anatomic Rasp with Stop 20x14, H05mm	RO1901AH0520X14	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 14x16, H05 mm	RO0121LB0514X16	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD14xH10	ISRO1416A10CA1	FDA UDI	Class II	Active
Romero Cervical Screw Remover	GN0010SRZZ	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 18x16, H12mm	RO1088L31218X16	FDA UDI	Class I	Active
Lordotic Trial Sizer 14x16, H06mm	RO1422LB0614X16	FDA UDI	Class I	Active
Ball Joint Drill with Stop D3.5xL14	RO2106V114	FDA UDI	Class I	Active

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