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Sign in to claim this brandCTL Medical Corporation
US
Last updated September 17, 2026
What CTL Medical Corporation makes
CTL Medical Corporation manufactures spinal fixation devices, including non-bioabsorbable bone screws, metallic and polymeric interbody fusion cages, and orthopaedic surgical kits for internal fixation. Their portfolio also includes reusable instrument trays and bone-screw rod systems for spinal stabilization procedures.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed 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 CTL Medical Corporation primarily manufacture?
CTL Medical Corporation specializes in spinal fixation devices, including non-bioabsorbable bone screws, metallic and polymeric interbody fusion cages, and orthopaedic surgical kits for internal fixation. Their portfolio also covers reusable instrument trays and bone-screw rod systems designed for spinal stabilization procedures. These devices are engineered to support surgical interventions in spinal orthopaedics.
Where is CTL Medical Corporation based, and how does that affect its regulatory standing?
CTL Medical Corporation is headquartered in the United States. As a U.S.-based manufacturer, its devices are subject to FDA regulations, including classification under FDA’s Class I and Class II categories. This classification determines the regulatory pathway for individual devices, such as pre-market notifications (510(k)) for Class II or general controls for Class I, but it does not imply company-wide approval.
Which regulatory registries or databases list CTL Medical Corporation’s devices?
CTL Medical Corporation’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system ensures traceability and transparency in the medical device supply chain, allowing healthcare providers, regulators, and patients to identify and verify specific devices. This listing is required for Class II devices and voluntary for Class I, but inclusion does not confirm individual device authorization.
How are CTL Medical Corporation’s devices classified under FDA regulations?
CTL Medical Corporation’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional premarket submissions like 510(k) clearances due to moderate risk. The classification depends on factors like the device’s intended use, potential harm, and design complexity, as outlined in FDA’s regulatory framework.
What does it mean for a CTL Medical Corporation device to be listed in the FDA’s UDI database?
Listing in the FDA’s UDI database means the device has been assigned a unique identifier, combining a device identifier (like a model number) and a production identifier (like a batch/lot number). This system enhances tracking throughout the device’s lifecycle—from manufacturing to patient use—by providing standardized, machine-readable information. However, listing alone does not confirm that the device has undergone FDA authorization; it simply ensures traceability and compliance with UDI requirements.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 2052 McKenzie Drive, Building 1, Carrollton, TX, 75006
- Website
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- Phone
- —
- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
- 3009051471
- DUNS Number
- —
Catalogue (6557)
Page 23 of 132| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Matisse | 013.7412 | FDA UDI | Class II | Active |
| Monet | 113.7511 | FDA UDI | Class II | Active |
| Cezanne-Ii | 104.6358 | FDA UDI | Class II | Active |
| Seurat | 126.2924 | FDA UDI | Class II | Active |
| Cezanne Ii | 018.2613 | FDA UDI | Class II | Active |
| RENOIR Posterior Cervico-Thoracic Fixation System | 012.7022 | FDA UDI | Class I | Active |
| Mondrian | 117.2799 | FDA UDI | Class II | Active |
| PICASSO MIS Spinal System | 016.6045 | FDA UDI | Class II | Active |
| Mondrian Alif | 106.7239 | FDA UDI | Class II | Active |
| Raphael | 015.7002 | FDA UDI | Class II | Active |
| RAPHAEL Pedicle Screw System | 015.4860 | FDA UDI | Class II | Active |
| CEZANNE II Lumbar Interbody Fusion Cage System | 103.7131 | FDA UDI | Class II | Active |
| Monet | 113.8070 | FDA UDI | Class II | Active |
| Generic Instruments | 100.2018 | FDA UDI | Class I | Active |
| Valeo Ii | 12.301.1510 | FDA UDI | Class II | Active |
| Valeo | 91.002.3310 | FDA UDI | Class II | Active |
| Monet | 113.1612 | FDA UDI | Class II | Active |
| H&H Big Cinch Abdominal Bandage | 1 | FDA UDI | Class I | Active |
| Valeo Ii | 12.302.2512 | FDA UDI | Class II | Active |
| Valeo Ii | 11.016.5122 | FDA UDI | Class II | Active |
| Raphael | 015.6300 | FDA UDI | Class II | Active |
| Valeo Ii | 11.020.5208 | FDA UDI | Class II | Active |
| Valeo C+csc | 11.209.1110 | FDA UDI | Class II | Active |
| Seurat | 126.1376 | FDA UDI | Class II | Active |
| Matisse | 013.7540 | FDA UDI | Class II | Active |
| Matisse | 013.4166 | FDA UDI | Class II | Active |
| DEGAS Anterior Cervical Plate System | 010.0120 | FDA UDI | Class II | Active |
| DEGAS Anterior Cervical Plate System | 010.0354 | FDA UDI | Class II | Active |
| Monet | 213.7327 | FDA UDI | Class II | Active |
| Taurus | 50-7000-005 | FDA UDI | Class II | Active |
| Seurat | 126.1226 | FDA UDI | Class II | Active |
| Matisse | 013.7779 | FDA UDI | Class II | Active |
| Matisse | 013.4166B | FDA UDI | Class II | Active |
| Mondrian | 103.1271 | FDA UDI | Class II | Active |
| Navigation | 109.7736 | FDA UDI | Class II | Active |
| Cezanne Ii | 018.2610 | FDA UDI | Class II | Active |
| Valeo | 11.009.1609 | FDA UDI | Class II | Active |
| RAPHAEL Pedicle Screw System | 015.3045 | FDA UDI | Class II | Active |
| Valeo Ii | 11.113.3810 | FDA UDI | Class II | Active |
| Seurat | 126.2091 | FDA UDI | Class II | Active |
| Matisse | 013.4167B | FDA UDI | Class II | Active |
| CEZANNE Lumbar Interbody Fusion Cage System | 017.1907 | FDA UDI | Class II | Active |
| Matisse | 013.4148 | FDA UDI | Class II | Active |
| Seurat | 126.2356 | FDA UDI | Class II | Active |
| Matisse | 013.4206B | FDA UDI | Class II | Active |
| Matisse | 013.4207 | FDA UDI | Class II | Active |
| Matisse | 013.7327 | FDA UDI | Class II | Active |
| Valeo Ii | 11.016.4410 | FDA UDI | Class II | Active |
| RODIN Expandable Lumbar Cage System | 027.0110 | FDA UDI | Class II | Active |
| Cezanne | 117.1811 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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FDA Recalls (6)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
CTL Medical Corporation has six FDA recall records initiated between July 5, 2018, and August 21, 2019. The records list two statuses: completed and terminated. The reasons provided include reports of device fracturing during insertion and a potential separation of the anti-toggle ring from the hex driver shaft, which could interfere with surgical procedures.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Aug 21, 2019 | Z-2501-2020 | — | completed | Reports received of the device fracturing during insertion. |
| Aug 21, 2019 | Z-2504-2020 | — | completed | Reports received of the device fracturing during insertion. |
| Aug 21, 2019 | Z-2503-2020 | — | completed | Reports received of the device fracturing during insertion. |
| Aug 21, 2019 | Z-2502-2020 | — | completed | Reports received of the device fracturing during insertion. |
| Jul 5, 2018 | Z-1031-2019 | — | terminated | the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the anti-toggle ring can be pressed into the pedicle screw head and cause separation of the screw from the housing upon tightening. if the anti-toggle ring remains in the pedicle crew head and can interfere with final tightening of the pedicle screw construct. this can lead to failure of the set crew and relies of the rod from the construct. |
| Jul 5, 2018 | Z-1030-2019 | — | terminated | the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the anti-toggle ring can be pressed into the pedicle screw head and cause separation of the screw from the housing upon tightening. if the anti-toggle ring remains in the pedicle crew head and can interfere with final tightening of the pedicle screw construct. this can lead to failure of the set crew and relies of the rod from the construct. |
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Hh Medical Co., Ltd. Ansan Gyeonggi · KR FEI 3038184658