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
ROMERO Lordotic Rasp 20x12, H08mm	RO1104LH0820X14	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W18xD12xH04	ISRO1218L04CB1	FDA UDI	Class II	Active
Anatomic Trial Sizer with stop 20x16, H04mm	RO0410AI0420X16	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD16xH07	ISRO1620L07CA1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W14xD14xH07	ISRO1414L07CA1	FDA UDI	Class II	Active
Romero Lordotic Rasp with Stop 18x14, H11mm	RO0177LF1118X14	FDA UDI	Class I	Active
Implant Holder with Drill Guides W18 x H08 mm	RO0824I308	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD16xH13	ISRO1620L13CA1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD12xH09	ISRO1216L09CA1	FDA UDI	Class II	Active
Anatomic Rasp with Stop 14x14, H10mm	RO1816AA1014X14	FDA UDI	Class I	Active
Anatomic Trial Sizer 16x16, H04mm	RO1250AD0416X16	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 16x12, H10 mm	RO0136LC1016X12	FDA UDI	Class I	Active
Anatomic Rasp 16x12, H11mm	RO1637AC1116X12	FDA UDI	Class I	Active
Anatomic Rasp 20x14, H08mm	RO1704AH0820X14	FDA UDI	Class I	Active
Anatomic Rasp 18x16, H12mm	RO1688A31218X16	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 16x14, H07 mm	RO0143L20716X14	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 18x12, H08mm	RO0164LE0818X12	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W14xD16xH09	ISRO1614L09CA1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD14xH12	ISRO1418A12CA1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W20xD12xH10	ISRO1220L10CB1	FDA UDI	Class II	Active
Implant Holder with Drill Guides W20 x H04 mm	RO0829I313	FDA UDI	Class I	Active
Lordotic Trial Sizer 16x16, H09mm	RO1455LD0916X16	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W14xD16xH07	ISRO1614A07CB1	FDA UDI	Class II	Active
Anatomic Rasp with Stop 20x14, H07mm	RO1903AH0720X14	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 20x16, H13mm	RO0219LI1320X16	FDA UDI	Class I	Active
Anatomic Rasp with Stop 20x12, H07mm	RO1893AG0720X12	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W18xD16xH05	ISRO1618A05CB1	FDA UDI	Class II	Active
Anatomic Trial Sizer 16x12, H04mm	RO1230AC0416X12	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 16x14, H06 mm	RO0142L20616X14	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W14xD16xH12	ISRO1614A12CA1	FDA UDI	Class II	Active
Lordotic Trial Sizer 14x16, H04mm	RO1420LB0414X16	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 20x16, H12mm	RO0418AI1220X16	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 20x16, H04mm	RO1110LI0420X16	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W16xD16xH05	ISRO1616A05CB1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD12xH05	ISRO1220L05CA1	FDA UDI	Class II	Active
Anatomic Trial Sizer with stop 14x12, H10mm	RO0306A11014X12	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD14xH13	ISRO1418A13CA1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD14xH07	ISRO1416A07CA1	FDA UDI	Class II	Active
Cervical Drill Primary with Stop L11	GN0073D111	FDA UDI	Class I	Active
Anatomic Rasp with Stop 18x12, H06mm	RO1862AE0618X12	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD16xH06	ISRO1618L06CA1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W16xD16xH13	ISRO1616A13CB1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD14xH10	ISRO1420L10CA1	FDA UDI	Class II	Active
Anatomic Trial Sizer with stop 16x14, H11mm	RO0347A21116X14	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD14xH09	ISRO1416A09CA1	FDA UDI	Class II	Active
Romero Lordotic Rasp with Stop 18x16, H12mm	RO0188L31218X16	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W16xD14xH09	ISRO1416L09CB1	FDA UDI	Class II	Active
Anatomic Rasp with Stop 16x12, H09mm	RO1835AC0916X12	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 18x16, H10mm	RO0186L31018X16	FDA UDI	Class I	Active
Lordotic Trial Sizer 16x14, H05mm	RO1441L20516X14	FDA UDI	Class I	Active

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