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Sign in to claim this brandcoLigne AG
US
Last updated May 24, 2026
What coLigne AG makes
coLigne AG manufactures polymeric spinal interbody fusion cages and non-sterile bone-screw internal spinal fixation systems. Their product line includes devices like the Trabis®, VBR, and ostaPek Interbody Fusion Cage, designed for spinal stabilization and fusion procedures. These devices are intended for use in surgical interventions to support vertebral alignment and bone healing.
The company’s devices are classified as Class II under regulatory frameworks, with products listed in the FDA’s Unique Device Identifier (UDI) database. These authorisations apply to spinal fixation and fusion solutions, ensuring compliance with U.S. medical device regulations. The manufacturer operates from 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 coLigne AG manufacture?
coLigne AG specializes in two primary device categories: polymeric spinal interbody fusion cages and non-sterile bone-screw internal spinal fixation systems. These devices are designed for spinal stabilization and fusion procedures, helping to support vertebral alignment and facilitate bone healing during surgical interventions. Examples include the Trabis® system, VBR, and the ostaPek Interbody Fusion Cage.
Where is coLigne AG based, and how does that affect its regulatory compliance?
coLigne AG is headquartered in the United States, which means its devices must comply with U.S. medical device regulations. Since the company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, they are subject to FDA oversight, including classification as Class II devices, which requires adherence to specific manufacturing, labeling, and post-market surveillance requirements.
Which regulatory registries or databases list coLigne AG’s devices?
coLigne AG’s devices are included in the FDA’s Unique Device Identifier (UDI) database, a publicly accessible registry that tracks medical devices authorized for sale in the U.S. This listing ensures traceability and transparency for healthcare providers, regulators, and patients, as it provides standardized identification for devices like the Trabis®, VBR, and ostaPek Interbody Fusion Cage.
How are coLigne AG’s devices classified under medical device regulations?
coLigne AG’s devices are classified as Class II under U.S. regulatory frameworks. This classification applies to spinal fixation and fusion products that pose moderate risks but require general or special controls to ensure safety and effectiveness. Class II devices undergo rigorous review to verify their performance, labeling accuracy, and manufacturing processes before authorization.
What is the purpose of the devices manufactured by coLigne AG?
coLigne AG’s devices are intended for spinal stabilization and fusion, specifically designed to address conditions requiring surgical intervention. The polymeric spinal interbody fusion cages and bone-screw internal fixation systems help maintain vertebral alignment, promote bone healing, and provide structural support during the fusion process. Examples like the Trabis® and ostaPek Interbody Fusion Cage are tailored for procedures where natural bone healing alone may be insufficient.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- coligne.com
- —
- —
- [email protected]
- Phone
- +41433438000
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 482467792
Catalogue (695)
Page 4 of 14| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Gii | 43.031 | FDA UDI | Class II | Active |
| ostaPek Interbody Fusion Cage | 20.014.154 | FDA UDI | Class II | Active |
| Vbr | 20.042.132807 | FDA UDI | Class II | Unknown |
| Gii | 32.425 NC | FDA UDI | Class II | Active |
| Gii | 32.735 NC | FDA UDI | Class II | Active |
| Vbr | 068.630.040 | FDA UDI | Class II | Active |
| Gii | 32.545 NC | FDA UDI | Class II | Active |
| ostaPek Interbody Fusion Cage | 2341 | FDA UDI | Class II | Active |
| ostaPek Interbody Fusion Cage | 65.092 | FDA UDI | Class II | Active |
| Gii | P60.42.012 | FDA UDI | Class II | Active |
| Gii | 036.013 | FDA UDI | Class II | Active |
| Acif | 4384 | FDA UDI | Class II | Active |
| Gii | 62.380 | FDA UDI | Class II | Active |
| ostaPek Interbody Fusion Cage | 21.357 | FDA UDI | Class II | Active |
| ostaPek Interbody Fusion Cage | 2321 | FDA UDI | Class II | Active |
| ostaPek Interbody Fusion Cage | 23.117 | FDA UDI | Class II | Active |
| Vbr | 2301 | FDA UDI | Class II | Unknown |
| ostaPek Interbody Fusion Cage | 66.092 | FDA UDI | Class II | Active |
| Gii | 32.760 | FDA UDI | Class II | Active |
| Gii | 32.645 NC | FDA UDI | Class II | Active |
| Vbr | 57.095 | FDA UDI | Class II | Unknown |
| ostaPek Interbody Fusion Cage | 20.042.132807 | FDA UDI | Class II | Active |
| Gii | 79.635 | FDA UDI | Class II | Active |
| ostaPek Interbody Fusion Cage | 23.112 | FDA UDI | Class II | Active |
| Gii | 32.860 | FDA UDI | Class II | Active |
| Vbr | 068.620 | FDA UDI | Class II | Active |
| Vbr | 4384 | FDA UDI | Class II | Active |
| Gii | 32.540 NC | FDA UDI | Class II | Active |
| Vbr | 068.241 | FDA UDI | Class II | Active |
| Vbr | 2351 | FDA UDI | Class II | Unknown |
| Vbr | 21.292 | FDA UDI | Class II | Unknown |
| Vbr | 4374 | FDA UDI | Class II | Unknown |
| Vbr | 4335 | FDA UDI | Class II | Unknown |
| Vbr | 053.051 | FDA UDI | Class II | Unknown |
| Gii | 32.640 LM | FDA UDI | Class II | Active |
| Vbr | 66.115 | FDA UDI | Class II | Unknown |
| Trabis® | 015.030.236 | FDA UDI | Class II | Active |
| ostaPek Interbody Fusion Cage | 2342 | FDA UDI | Class II | Active |
| Vbr | P15.010.376 | FDA UDI | Class II | Active |
| Gii | 83.760 | FDA UDI | Class II | Active |
| Vbr | 4470 | FDA UDI | Class II | Unknown |
| ostaPek Interbody Fusion Cage | 4334 | FDA UDI | Class II | Active |
| Gii | 20.036.545 | FDA UDI | Class II | Active |
| Trabis® | P15-010-04 | FDA UDI | Class II | Active |
| ostaPek Interbody Fusion Cage | 20.043.08 | FDA UDI | Class II | Active |
| Gii | 78.655 | FDA UDI | Class II | Active |
| Gii | 32.950 | FDA UDI | Class II | Active |
| Gii | 78.750 | FDA UDI | Class II | Active |
| Vbr | P45.2333 | FDA UDI | Class II | Unknown |
| Acif | 2383 | FDA UDI | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Coligne Ag ZURICH · CH FEI 1000493591