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, H06mm	RO0402AH0620X14	FDA UDI	Class I	Active
Anatomic Rasp 14x14, H13mm	RO1619AA1314X14	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD16xH12	ISRO1618A12CA1	FDA UDI	Class II	Active
Anatomic Trial Sizer with stop 16x16, H11mm	RO0357AD1116X16	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W18xD14xH05	ISRO1418L05CB1	FDA UDI	Class II	Active
Anatomic Rasp with Stop 18x14, H08mm	RO1874AF0818X14	FDA UDI	Class I	Active
Lordotic Trial Sizer 20x16, H09mm	RO1515LI0920X16	FDA UDI	Class I	Active
Implant Holder with Drill Guides W14 x H05 mm	RO0801I105	FDA UDI	Class I	Active
Cervical Drill Revision with Stop L10	GN0092D210	FDA UDI	Class I	Active
Implant Holder with Drill Guides W16 x H05 mm	RO0811I205	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W18xD12xH08	ISRO1218A08CB1	FDA UDI	Class II	Active
Anatomic Trial Sizer 16x16, H06mm	RO1252AD0616X16	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W14xD16xH11	ISRO1614A11CB1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W14xD16xH06	ISRO1614L06CB1	FDA UDI	Class II	Active
Romero Lordotic Rasp with Stop 20x16, H10mm	RO0216LI1020X16	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 14x12, H13mm	RO0509L11314X12	FDA UDI	Class I	Active
Lordotic Trial Sizer 20x12, H06mm	RO1492LG0620X12	FDA UDI	Class I	Active
Anatomic Rasp with Stop 20x14, H04mm	RO1900AH0420X14	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD12xH12	ISRO1216A12CA1	FDA UDI	Class II	Active
Implant Holder with Drill Guides W16 x H11 mm	RO0817I211	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 20x14, H10mm	RO0406AH1020X14	FDA UDI	Class I	Active
Implant Holder with Drill Guides W14 x H07 mm	RO0803I107	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 16x12, H05 mm	RO0131LC0516X12	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 14x12, H04 mm	RO1000L10414x12	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 20x14, H11mm	RO0407AH1120X14	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 20x14, H04mm	RO0400AH0420X14	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 16x14, H11mm	RO0547L21116X14	FDA UDI	Class I	Active
Anatomic Trial Sizer 20x16, H08mm	RO1314AI0820X16	FDA UDI	Class I	Active
Lordotic Trial Sizer 14x12, H05mm	RO1401L10514X12	FDA UDI	Class I	Active
Anatomic Rasp with Stop 16x12, H05mm	RO1831AC0516X12	FDA UDI	Class I	Active
Anatomic Rasp 14x12, H06mm	RO1602A10614X12	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 14x14, H12mm	RO0518LA1214X14	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 20x14, H09mm	RO0405AH0920X14	FDA UDI	Class I	Active
ROMERO Self Drilling Screw, D3.5xL09mm	ISRO35D09SC2	FDA UDI	Class II	Active
ROMERO Lordotic Rasp 16x12, H12mm	RO1038LC1216X12	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 16x16, H09mm	RO1055LD0916X16	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD16xH09	ISRO1620L09CA1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W20xD14xH12	ISRO1420L12CB1	FDA UDI	Class II	Active
Anatomic Trial Sizer 16x12, H05mm	RO1231AC0516X12	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W16xD14xH13	ISRO1416A13CB1	FDA UDI	Class II	Active
ROMERO Lordotic Rasp 18x14, H04mm	RO1070LF0418X14	FDA UDI	Class I	Active
Anatomic Rasp with Stop 16x14, H05mm	RO1841A20516X14	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 20x14, H09mm	RO0205LH0920X14	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 14x12, H08 mm	RO0104L10814X12	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 14x16, H09mm	RO1025LB0914X16	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 18x12, H04mm	RO0360AE0418X12	FDA UDI	Class I	Active
Awl	RO0010AZZZ	FDA UDI	Class I	Active
Cervical Tap Primary with Stop L13	GN0055T113	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W16xD12xH07	ISRO1216L07CB1	FDA UDI	Class II	Active
Anatomic Trial Sizer 18x12, H04mm	RO1260AE0418X12	FDA UDI	Class I	Active

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