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Sign in to claim this brandCTL Medical Corporation
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 2052 McKenzie Drive, Building 1, Carrollton, TX, 75006
- Website
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- —
- —
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- Phone
- —
- PRRC Contact
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- EUDAMED SRN
- —
- FDA FEI Number
- 3009051471
- DUNS Number
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Catalogue (6557)
Page 6 of 132| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Navigation | 109.7531 | FDA UDI | Class II | Active |
| RAPHAEL Pedicle Screw System | 115.4250 | FDA UDI | Class II | Active |
| RAPHAEL Pedicle Screw System | 115.2465 | FDA UDI | Class II | Active |
| RAPHAEL Pedicle Screw System | 115.0240 | FDA UDI | Class II | Active |
| Generic | 100.7030 | FDA UDI | Class I | Active |
| CEZANNE Lumbar Interbody Fusion Cage System | 017.0047 | FDA UDI | Class II | Active |
| Generic | 100.7003 | FDA UDI | Class I | Active |
| CEZANNE Lumbar Interbody Fusion Cage System | 017.0906 | FDA UDI | Class II | Active |
| MATISSE Anterior Cervical Interbody Fusion Cage System | 013.4156 | FDA UDI | Class II | Active |
| Matisse | 013.4110B | FDA UDI | Class II | Active |
| Mondrian | 127.0715 | FDA UDI | Class II | Active |
| PICASSO MIS Spinal System | 016.1573 | FDA UDI | Class II | Active |
| Mondrian Alif | 120.7235 | FDA UDI | Class II | Active |
| CEZANNE Lumbar Interbody Fusion Cage System | 017.0313 | FDA UDI | Class II | Active |
| Cezanne | 117.1514 | FDA UDI | Class II | Active |
| VAN GOGH Anterior Cervical Plate System | 011.1016 | FDA UDI | Class II | Active |
| Valeo Ii | 11.111.5316 | FDA UDI | Class II | Active |
| Valeo Ii | 11.020.5308 | FDA UDI | Class II | Active |
| Cezanne | 117.1814 | FDA UDI | Class II | Active |
| Matisse | 013.7542 | FDA UDI | Class II | Active |
| CEZANNE II Lumbar Interbody Fusion Cage System | 018.4211 | FDA UDI | Class II | Active |
| RODIN Expandable Lumbar Cage System | 027.7350 | FDA UDI | Class II | Active |
| Raphael | 015.3648 | FDA UDI | Class II | Active |
| Monet | 113.7503 | FDA UDI | Class II | Active |
| Raphael | 015.3667 | FDA UDI | Class II | Active |
| VAN GOGH Anterior Cervical Plate System | 011.7122 | FDA UDI | Class I | Active |
| Generic | 100.2022 | FDA UDI | Class I | Active |
| RAPHAEL Pedicle Screw System | 115.1645 | FDA UDI | Class II | Active |
| RAPHAEL Pedicle Screw System | 115.4425 | FDA UDI | Class II | Active |
| MATISSE Anterior Cervical Interbody Fusion Cage System | 013.4199 | FDA UDI | Class II | Active |
| Monet | 113.0715 | FDA UDI | Class II | Active |
| Mondrian | 127.1891 | FDA UDI | Class II | Active |
| Matisse | 013.4806B | FDA UDI | Class II | Active |
| CEZANNE II Lumbar Interbody Fusion Cage System | 103.7052 | FDA UDI | Class II | Active |
| Mondrian Plif | 127.2753 | FDA UDI | Class II | Active |
| Taurus | 50-2000-001 | FDA UDI | Class II | Active |
| RENOIR Posterior Cervico-Thoracic Fixation System | 012.1414 | FDA UDI | Class II | Active |
| DEGAS Anterior Cervical Plate System | 010.8720 | FDA UDI | Class I | Active |
| Raphael | 015.4352 | FDA UDI | Class II | Active |
| CEZANNE Lumbar Interbody Fusion Cage System | 017.0807 | FDA UDI | Class II | Active |
| Cezanne-Ii | 128.5230 | FDA UDI | Class II | Active |
| Mondrian | 127.0876 | FDA UDI | Class II | Active |
| PICASSO MIS Spinal System | 016.7100 | FDA UDI | Class I | Active |
| Mondrian | 127.1408 | FDA UDI | Class II | Active |
| CEZANNE Lumbar Interbody Fusion Cage System | 017.0913 | FDA UDI | Class II | Active |
| RAPHAEL Pedicle Screw System | 015.4150 | FDA UDI | Class II | Active |
| Generic Instruments | 100.7080 | FDA UDI | Class I | Active |
| RENOIR Posterior Cervico-Thoracic Fixation System | 012.1404 | FDA UDI | Class II | Active |
| Navigation | 109.7765 | FDA UDI | Class II | Active |
| Generic | 061.7120 | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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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.
| 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