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
Implant Holder with Drill Guides W16 x H13 mm	RO0819I213	FDA UDI	Class I	Active
Lordotic Trial Sizer 14x12, H04mm	RO1400L10414X12	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 14x14, H07mm	RO0513LA0714X14	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD16xH04	ISRO1618L04CA1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD14xH08	ISRO1420A08CA1	FDA UDI	Class II	Active
Lordotic Trial Sizer 14x14, H09mm	RO1415LA0914X14	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD12xH05	ISRO1218A05CA1	FDA UDI	Class II	Active
ROMERO Self Tapping Screw, D3.5xL08mm	ISRO35T08SC2	FDA UDI	Class II	Active
Anatomic Trial Sizer 18x14, H09mm	RO1275AF0918X14	FDA UDI	Class I	Active
Romero Universal Double Guide Tap	RO2120T1US	FDA UDI	Class I	Active
Anatomic Rasp with Stop 14x14, H07mm	RO1813AA0714X14	FDA UDI	Class I	Active
Anatomic Trial Sizer 14x14, H11mm	RO1217AA1114X14	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 16x16, H07mm	RO0553LD0716X16	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 16x12, H09mm	RO1035LC0916X12	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 20x12, H10mm	RO1106LH1020X14	FDA UDI	Class I	Active
Lordotic Trial Sizer 20x14, H12mm	RO1508LH1220X14	FDA UDI	Class I	Active
Cervical Tap Primary with Stop L17	GN0059T117	FDA UDI	Class I	Active
Implant Holder with Drill Guides W20 x H12 mm	RO0838I412	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD12xH08	ISRO1220L08CA1	FDA UDI	Class II	Active
Anatomic Rasp 18x14, H11mm	RO1677AF1118X14	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 18x14, H10mm	RO1076LF1018X14	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W16xD16xH07	ISRO1616L07CB1	FDA UDI	Class II	Active
Anatomic Trial Sizer 16x16, H09mm	RO1255AD0916X16	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 14x16, H06mm	RO1022LB0614X16	FDA UDI	Class I	Active
Anatomic Rasp with Stop 18x16, H06mm	RO1882A30618X16	FDA UDI	Class I	Active
Cervical Tap Primary with Stop L22	GN0064T122	FDA UDI	Class I	Active
Anatomic Rasp with Stop 16x16, H07mm	RO1853AD0716X16	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W16xD12xH12	ISRO1216A12CB1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W18xD14xH06	ISRO1418L06CB1	FDA UDI	Class II	Active
Romero Lordotic Rasp with Stop 18x12, H12mm	RO0168LE1218X12	FDA UDI	Class I	Active
Quick Connect Awl	RO0015QCAZ	FDA UDI	Class I	Active
Anatomic Rasp with Stop 20x14, H13mm	RO1909AH1320X14	FDA UDI	Class I	Active
Anatomic Rasp with Stop 18x16, H12mm	RO1888A31218X16	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W20xD14xH08	ISRO1420L08CB1	FDA UDI	Class II	Active
Implant Holder with Drill Guides W14 x H13 mm	RO0809I113	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W20xD14xH13	ISRO1420L13CB1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD16xH13	ISRO1618L13CA1	FDA UDI	Class II	Active
ROMERO Lordotic Rasp 18x12, H09mm	RO1065LE0918X12	FDA UDI	Class I	Active
Lordotic Trial Sizer 20x14, H11mm	RO1507LH1120X14	FDA UDI	Class I	Active
Cervical Drill Revision with Stop L17	GN0099D217	FDA UDI	Class I	Active
Cervical Drill Primary with Stop L20	GN0082D120	FDA UDI	Class I	Active
Lordotic Trial Sizer 14x12, H10mm	RO1406L11014X12	FDA UDI	Class I	Active
Narrow Introducer for Standard Heights	RO0003NISH	FDA UDI	Class I	Active
ROMERO Self Drilling Screw, D3.5xL18mm	ISRO35D18SC2	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD14xH04	ISRO1418L04CA1	FDA UDI	Class II	Active
Anatomic Trial Sizer with stop 20x14, H13mm	RO0409AH1320X14	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 20x16, H05mm	RO0611LI0520X16	FDA UDI	Class I	Active
Lordotic Trial Sizer 16x14, H07mm	RO1443L20716X14	FDA UDI	Class I	Active
ROMERO Self Tapping Screw, D3.5xL18mm	ISRO35T18SC2	FDA UDI	Class II	Active
Lordotic Trial Sizer 20x16, H05mm	RO1511LI0520X16	FDA UDI	Class I	Active

Spineup, Inc.

What Spineup, Inc. makes

Frequently asked questions

Information

Catalogue (1623)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities