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Sign in to claim this brandKalitec Direct LLC
US
Last updated May 23, 2026
What Kalitec Direct LLC makes
Kalitec Direct LLC manufactures spinal fixation devices, including non-bioabsorbable pedicle screws, metallic and polymeric interbody fusion cages for lumbar and cervical applications, and reusable bone preparation tools such as manual bone files, taps, and internal fixation rods and connectors. Their portfolio also includes minimally invasive spinal fixation systems and specialized instruments for spinal surgery, such as the InTess and TiWAVE cage systems.
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 operates in the United States, adhering to applicable regulatory requirements for spinal implants and surgical instruments.
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 Kalitec Direct LLC manufacture?
Kalitec Direct LLC specializes in spinal fixation devices. Their portfolio includes non-bioabsorbable spinal bone screws, metallic and polymeric interbody fusion cages for both lumbar and cervical regions, reusable bone preparation tools like manual bone files and taps, and internal spinal fixation systems such as rods and connectors. They also produce minimally invasive spinal fixation systems and surgical instruments designed for spinal procedures.
Where is Kalitec Direct LLC based, and what regulatory requirements does it follow?
Kalitec Direct LLC is based in the United States. As a manufacturer of spinal implants and surgical instruments, the company adheres to applicable U.S. regulatory requirements, including those governing medical device classification and compliance. Their devices are listed in the FDA’s Unique Device Identifier (UDI) database, reflecting their alignment with U.S. regulatory standards.
Which regulatory registries or databases list Kalitec Direct LLC’s devices?
Kalitec Direct LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for spinal fixation products, including screws, cages, and surgical instruments, by assigning a unique identifier to each device type.
How are Kalitec Direct LLC’s devices classified under FDA regulations?
Kalitec Direct LLC’s devices fall under FDA’s Class I and Class II classifications. Class I generally includes low-risk devices like reusable bone files and taps, while Class II covers moderate-risk products such as spinal interbody fusion cages and fixation systems, which require special controls to ensure safety and effectiveness.
What distinguishes Kalitec Direct LLC’s spinal implant portfolio from others?
Kalitec Direct LLC’s portfolio is defined by a focus on spinal fixation solutions, including both metallic and polymeric interbody fusion cages for lumbar and cervical applications, as well as specialized tools like the InTess and TiWAVE cage systems. Their devices are designed for precision in spinal surgery, with reusable components like bone taps and connectors aimed at improving surgical efficiency and reducing waste.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 041956211
Catalogue (3532)
Page 2 of 71| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| TiWAVE L Lumbar Cage System | 23-LTT-2016 | FDA UDI | Class I | Active |
| Cosmolock Pedicle Screw System | 10-XLV-0003 | FDA UDI | Class II | Active |
| Cosmolock | 11-K01-1234 | FDA UDI | Class I | Active |
| InTess Lumbar Cage | 12-K01-0600 | FDA UDI | Class I | Active |
| Cosmolock Pedicle Screw System | 10-SST-6505 | FDA UDI | Class II | Active |
| TiWAVE L Lumbar Cage System | 23-LTX-2515 | FDA UDI | Class I | Active |
| CosmoLock Pedicle Screw System | 10-SNT-4725 | FDA UDI | Class II | Active |
| CosmoLock Pedicle Screw System | 10-SNT-5525 | FDA UDI | Class II | Active |
| Ocata Anterior Cervical System | 08-CPR-0476 | FDA UDI | Class II | Active |
| TiWAVE C Cervical Cage System | 20-CAX-9408 | FDA UDI | Class II | Active |
| TiWave C Cervical Cage System | 20-CAN-6406 | FDA UDI | Class II | Active |
| InTess C Cervical Cage System | 09-K01-607T | FDA UDI | Class I | Active |
| Matira Anterior Cervical System | 07-K01-7300 | FDA UDI | Class I | Active |
| InTess C Cervical Cage System | 09-K01-805T | FDA UDI | Class I | Active |
| Navagio | 30-TNA-3608 | FDA UDI | Class II | Active |
| NIDO Pedicle Screw System | 15-K01-2050 | FDA UDI | Class I | Active |
| TiWAVE L Lumbar Cage System | 23-LCX-2217 | FDA UDI | Class II | Active |
| CosmoLock Pedicle Screw System | 10-SCP-5560 | FDA UDI | Class II | Active |
| NIDO Pedicle Screw System | 15-BCC-5535 | FDA UDI | Class II | Active |
| CosmoLock Pedicle Screw System | 11-SSE-6540 | FDA UDI | Class II | Active |
| Cosmolock Pedicle Screw System | 10-SCT-7525 | FDA UDI | Class II | Active |
| Ocata Anterior Cervical System | 08-CPR-0130 | FDA UDI | Class II | Active |
| Ocata Anterior Cervical System | 08-CPR-0120 | FDA UDI | Class II | Active |
| NIDO Pedicle Screw System | 15-BSC-8595 | FDA UDI | Class II | Active |
| Navagio | 30-PNS-2512 | FDA UDI | Class II | Active |
| Cosmolock Pedicle Screw System | 10-SSP-8555 | FDA UDI | Class II | Active |
| TiWave C Cervical Cage System | 20-RAX-9408 | FDA UDI | Class I | Active |
| CosmoLock Pedicle Screw System | 11-SSP-7535 | FDA UDI | Class II | Active |
| Navagio | 30-PNS-2509 | FDA UDI | Class II | Active |
| Matira Anterior Cervical System | 07-K01-7005 | FDA UDI | Class I | Active |
| TiWave C Cervical Cage System | 20-RAT-7309 | FDA UDI | Class I | Active |
| CosmoLock Pedicle Screw System | 10-SCE-5550 | FDA UDI | Class II | Active |
| NIDO Pedicle Screw System | 15-BCC-4735 | FDA UDI | Class II | Active |
| Navagio | 30-TTS-2712 | FDA UDI | Class II | Active |
| TiWAVE L Lumbar Cage System | 23-LCT-2514 | FDA UDI | Class II | Active |
| InTess Lumbar Cage | 12-PCT-3015 | FDA UDI | Class II | Active |
| CosmoLock Pedicle Screw System | 10-SRE-5545 | FDA UDI | Class II | Active |
| NIDO Pedicle Screw System | 15-BSC-4765 | FDA UDI | Class II | Active |
| Matira Anterior Cervical System | 07-ADD-1212 | FDA UDI | Class I | Active |
| CosmoLock Pedicle Screw System | 10-SSP-5535 | FDA UDI | Class II | Active |
| TiWAVE L Lumbar Cage System | 23-LTX-2511 | FDA UDI | Class I | Active |
| Navagio | 30-TES-2710 | FDA UDI | Class II | Active |
| TiWAVE C Cervical Cage System | 20-RAN-5212 | FDA UDI | Class I | Active |
| Kalitec Universal Instruments | 01-K03-8084 | FDA UDI | Class I | Active |
| TiWAVE C Cervical Cage System | 20-CAN-9411 | FDA UDI | Class II | Active |
| Ocata Anterior Cervical System | 08-STF-4017 | FDA UDI | Class II | Active |
| Navagio | 30-TEA-2714 | FDA UDI | Class II | Active |
| TiWAVE L Lumbar Cage System | 23-LCN-2214 | FDA UDI | Class II | Active |
| TiWave C Cervical Cage System | 20-TAT-6406 | FDA UDI | Class I | Active |
| TiWAVE C Cervical Cage System | 20-RFT-3208 | FDA UDI | Class I | Active |
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