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
Awl With Stop	RO0016ASZZ	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 16x14, H11 mm	RO0147L21116X14	FDA UDI	Class I	Active
Anatomic Trial Sizer 20x14, H07mm	RO1303AH0720X14	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W14xD16xH07	ISRO1614A07CA1	FDA UDI	Class II	Active
ROMERO Lordotic Rasp 18x16, H06mm	RO1082L30618X16	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 16x14, H04mm	RO0540L20416X14	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W20xD12xH06	ISRO1220A06CB1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD16xH13	ISRO1618A13CA1	FDA UDI	Class II	Active
Lordotic Trial Sizer with Stop 18x16, H13mm	RO0589L31318X16	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 16x16, H08mm	RO1054LD0816X16	FDA UDI	Class I	Active
Lordotic Trial Sizer 16x16, H04mm	RO1450LD0416X16	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD14xH11	ISRO1420L11CA1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W20xD12xH09	ISRO1220A09CB1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W16xD16xH06	ISRO1616A06CB1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD16xH11	ISRO1620A11CA1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD12xH06	ISRO1220L06CA1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W16xD12xH12	ISRO1216L12CB1	FDA UDI	Class II	Active
ROMERO Lordotic Rasp 18x14, H06mm	RO1072LF0618X14	FDA UDI	Class I	Active
ROMERO Lordotic Rasp 20x12, H11mm	RO1097LG1120X12	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 20x16, H09mm	RO0215LI0920X16	FDA UDI	Class I	Active
Anatomic Trial Sizer 20x16, H04mm	RO1310AI0420X16	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 16x12, H06mm	RO0332AC0616X12	FDA UDI	Class I	Active
Anatomic Rasp 20x16, H10mm	RO1716AI1020X16	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 14x12, H05 mm	RO0101L10514X12	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 20x12, H09mm	RO0395AG0920X12	FDA UDI	Class I	Active
Cervical Drill Primary with Stop L10	GN0072D110	FDA UDI	Class I	Active
Ball Joint Drill with Stop D3.5xL16	RO2108V116	FDA UDI	Class I	Active
Anatomic Rasp with Stop 18x16, H05mm	RO1881A30518X16	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 14x12, H08mm	RO0304A10814X12	FDA UDI	Class I	Active
ROMERO Self Drilling Screw, D4.0xL17mm	ISRO40D17SC2	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD16xH08	ISRO1616A08CA1	FDA UDI	Class II	Active
ROMERO Self Drilling Screw, D3.5xL11mm	ISRO35D11SC2	FDA UDI	Class II	Active
Lordotic Trial Sizer 16x12, H12mm	RO1438LC1216X12	FDA UDI	Class I	Active
Implant Holder with Drill Guides W18 x H05 mm	RO0821I305	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 14x12, H07mm	RO0503L10714X12	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W16xD12xH11	ISRO1216A11CB1	FDA UDI	Class II	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD16xH12	ISRO1616L12CA1	FDA UDI	Class II	Active
ROMERO CERVICAL CAGE, W16xD14xH05	ISRO1416L05CB1	FDA UDI	Class II	Active
Anatomic Trial Sizer 14x14, H13mm	RO1219AA1314X14	FDA UDI	Class I	Active
Lordotic Trial Sizer with Stop 18x12, H12mm	RO0568LE1218X12	FDA UDI	Class I	Active
Anatomic Trial Sizer 16x14, H05mm	RO1241A20516X14	FDA UDI	Class I	Active
Anatomic Trial Sizer with stop 16x14, H13mm	RO0349A21316X14	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD16xH12	ISRO1620A12CA1	FDA UDI	Class II	Active
Anatomic Rasp with Stop 16x14, H13mm	RO1849A21316X14	FDA UDI	Class I	Active
Anatomic Trial Sizer 20x16, H07mm	RO1313AI0720X16	FDA UDI	Class I	Active
ROMERO SELF-ANCHORED CERVICAL CAGE, W14xD12xH07	ISRO1214A07CA1	FDA UDI	Class II	Active
Anatomic Rasp 18x14, H08mm	RO1674AF0818X14	FDA UDI	Class I	Active
Romero Lordotic Rasp with Stop 18x16, H04mm	RO0180L30418X16	FDA UDI	Class I	Active
ROMERO CERVICAL CAGE, W14xD14xH12	ISRO1414A12CB1	FDA UDI	Class II	Active
ROMERO Lordotic Rasp 16x16, H05mm	RO1051LD0516X16	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