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Sign in to claim this brandSpineup, Inc.
US
Last updated May 24, 2026
What Spineup, Inc. makes
Spineup, Inc. manufactures spinal interbody fusion cages made from polymeric materials, including lordotic and cervical designs such as the ROMERO Self-Anchored and standard ROMERO cages. Their portfolio also includes reusable surgical instruments for orthopaedic procedures, such as bone files, rasps, drills, taps, and positioning tools, as well as trial sizers and implant holders for spinal implant placement.
The company’s devices are regulated under FDA classification as Class I and Class II, with listings in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Spineup, Inc. manufacture?
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.
Where is Spineup, Inc. based, and how does that affect its regulatory oversight?
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.
Are Spineup, Inc.’s devices listed in any regulatory registries, and why does this matter?
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.
How are Spineup, Inc.’s spinal devices classified by the FDA, and what does that mean for their use?
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.
What distinguishes Spineup, Inc.’s reusable surgical instruments from their implantable devices?
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.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- upgroup.tech
- —
- —
- [email protected]
- Phone
- 786-910-0234
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 116999578
Catalogue (1623)
Page 23 of 33| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Lordotic Trial Sizer 14x14, H10mm | RO1416LA1014X14 | FDA UDI | Class I | Active |
| ROMERO CERVICAL CAGE, W20xD14xH12 | ISRO1420A12CB1 | FDA UDI | Class II | Active |
| Anatomic Rasp with Stop 18x12, H05mm | RO1861AE0518X12 | FDA UDI | Class I | Active |
| ROMERO CERVICAL CAGE, W14xD16xH05 | ISRO1614L05CB1 | FDA UDI | Class II | Active |
| Anatomic Rasp with Stop 16x14, H04mm | RO1840A20416X14 | FDA UDI | Class I | Active |
| Lordotic Trial Sizer 20x16, H12mm | RO1518LI1220X16 | FDA UDI | Class I | Active |
| Anatomic Rasp with Stop 16x14, H12mm | RO1848A21216X14 | FDA UDI | Class I | Active |
| Anatomic Trial Sizer 14x16, H07mm | RO1223AB0714X16 | FDA UDI | Class I | Active |
| ROMERO Self Tapping Screw, D3.5xL20mm | ISRO35T20SC2 | FDA UDI | Class II | Active |
| ROMERO Lordotic Rasp 14x12, H05 mm | RO1001L10514x12 | FDA UDI | Class I | Active |
| Romero Lordotic Rasp with Stop 20x12, H08mm | RO0194LG0820X12 | FDA UDI | Class I | Active |
| ROMERO CERVICAL CAGE, W16xD12xH13 | ISRO1216A13CB1 | FDA UDI | Class II | Active |
| Ball Joint Drill with Stop D3.5xL20 | RO2112V120 | FDA UDI | Class I | Active |
| Romero Lordotic Rasp with Stop 14x16, H04 mm | RO0120LB0414X16 | FDA UDI | Class I | Active |
| Lordotic Trial Sizer 20x14, H13mm | RO1509LH1320X14 | FDA UDI | Class I | Active |
| Lordotic Trial Sizer with Stop 16x16, H05mm | RO0551LD0516X16 | FDA UDI | Class I | Active |
| ROMERO CERVICAL CAGE, W18xD16xH13 | ISRO1618L13CB1 | FDA UDI | Class II | Active |
| Lordotic Trial Sizer 16x12, H10mm | RO1436LC1016X12 | FDA UDI | Class I | Active |
| ROMERO CERVICAL CAGE, W14xD14xH09 | ISRO1414A09CB1 | FDA UDI | Class II | Active |
| ROMERO Lordotic Rasp 16x16, H10mm | RO1056LD1016X16 | FDA UDI | Class I | Active |
| ROMERO CERVICAL CAGE, W16xD12xH04 | ISRO1216L04CB1 | FDA UDI | Class II | Active |
| Romero Lordotic Rasp with Stop 14x14, H13 mm | RO0119LA1314X14 | FDA UDI | Class I | Active |
| ROMERO CERVICAL CAGE, W16xD12xH08 | ISRO1216L08CB1 | FDA UDI | Class II | Active |
| ROMERO CERVICAL CAGE, W14xD16xH12 | ISRO1614L12CB1 | FDA UDI | Class II | Active |
| Lordotic Trial Sizer with Stop 14x14, H06mm | RO0512LA0614X14 | FDA UDI | Class I | Active |
| ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD14xH11 | ISRO1420A11CA1 | FDA UDI | Class II | Active |
| Anatomic Trial Sizer with stop 20x12, H10mm | RO0396AG1020X12 | FDA UDI | Class I | Active |
| Lordotic Trial Sizer 18x16, H11mm | RO1487L31118X16 | FDA UDI | Class I | Active |
| ROMERO Lordotic Rasp 14x16, H10mm | RO1026LB1014X16 | FDA UDI | Class I | Active |
| Anatomic Rasp 18x14, H07mm | RO1673AF0718X14 | FDA UDI | Class I | Active |
| Anatomic Trial Sizer with stop 20x12, H13mm | RO0399AG1320X12 | FDA UDI | Class I | Active |
| Anatomic Trial Sizer 18x16, H06mm | RO1282A30618X16 | FDA UDI | Class I | Active |
| Anatomic Rasp 14x12, H10mm | RO1606A11014X12 | FDA UDI | Class I | Active |
| Cervical Tap Primary with Stop L19 | GN0061T119 | FDA UDI | Class I | Active |
| Lordotic Trial Sizer with Stop 18x16, H08mm | RO0584L30818X16 | FDA UDI | Class I | Active |
| Cervical Drill Revision with Stop L11 | GN0093D211 | FDA UDI | Class I | Active |
| ROMERO CERVICAL CAGE, W18xD16xH12 | ISRO1618L12CB1 | FDA UDI | Class II | Active |
| Anatomic Trial Sizer with stop 16x12, H13mm | RO0339AC1316X12 | FDA UDI | Class I | Active |
| ROMERO Self Tapping Screw, D3.5xL14mm | ISRO35T14SC2 | FDA UDI | Class II | Active |
| ROMERO CERVICAL CAGE, W14xD16xH12 | ISRO1614A12CB1 | FDA UDI | Class II | Active |
| Lordotic Trial Sizer 14x16, H10mm | RO1426LB1014X16 | FDA UDI | Class I | Active |
| Anatomic Rasp 16x14, H09mm | RO1645A20916X14 | FDA UDI | Class I | Active |
| ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD12xH05 | ISRO1216L05CA1 | FDA UDI | Class II | Active |
| Anatomic Trial Sizer with stop 16x14, H04mm | RO0340A20416X14 | FDA UDI | Class I | Active |
| Anatomic Rasp 20x14, H04mm | RO1700AH0420X14 | FDA UDI | Class I | Active |
| ROMERO Lordotic Rasp 20x16, H07mm | RO1113LI0720X16 | FDA UDI | Class I | Active |
| Lordotic Trial Sizer with Stop 14x16, H07mm | RO0523LB0714X16 | FDA UDI | Class I | Active |
| ROMERO SELF-ANCHORED CERVICAL CAGE, W16xD14xH04 | ISRO1416A04CA1 | FDA UDI | Class II | Active |
| Romero Lordotic Rasp with Stop 16x12, H04 mm | RO0130LC0416X12 | FDA UDI | Class I | Active |
| Anatomic Rasp 16x14, H06mm | RO1642A20616X14 | FDA UDI | Class I | Active |
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