Question 1

What types of medical devices does Kalitec Direct LLC manufacture?

Accepted Answer

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.

Question 2

Where is Kalitec Direct LLC based, and what regulatory requirements does it follow?

Accepted Answer

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.

Question 3

Which regulatory registries or databases list Kalitec Direct LLC’s devices?

Accepted Answer

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.

Question 4

How are Kalitec Direct LLC’s devices classified under FDA regulations?

Accepted Answer

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.

Question 5

What distinguishes Kalitec Direct LLC’s spinal implant portfolio from others?

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
Cosmolock Pedicle Screw System	10-SCP-7565	FDA UDI	Class II	Active
TiWAVE C Cervical Cage System	20-RAT-5209	FDA UDI	Class I	Active
TiWAVE L Lumbar Cage System	23-LCX-2512	FDA UDI	Class II	Active
Navagio	30-TNC-3613	FDA UDI	Class II	Active
TiWAVE C Cervical Cage System	20-TAX-3206	FDA UDI	Class I	Active
Matira Anterior Cervical System	07-K01-5300	FDA UDI	Class I	Active
NIDO Pedicle Screw System	15-BCC-6580	FDA UDI	Class II	Active
TiWAVE L Lumbar Cage System	23-LTX-2012	FDA UDI	Class I	Active
TiWAVE L Lumbar Cage System	23-LTN-2209	FDA UDI	Class I	Active
TiWAVE C Cervical Cage System	20-RAT-3205	FDA UDI	Class I	Active
Cosmolock Pedicle Screw System	10-BRC-0055	FDA UDI	Class II	Active
TiWAVE L Lumbar Cage System	23-LTN-2017	FDA UDI	Class I	Active
NIDO Pedicle Screw System	15-BSC-9535	FDA UDI	Class II	Active
Matira Anterior Cervical System	07-CPR-0234	FDA UDI	Class II	Active
TiWAVE C Cervical Cage System	20-RAN-3210	FDA UDI	Class I	Active
NIDO Pedicle Screw System	15-BSC-6575	FDA UDI	Class II	Active
TiWAVE L Lumbar Cage System	23-K01-0115	FDA UDI	Class I	Active
Cosmolock	11-K01-0043	FDA UDI	Class I	Active
Cosmolock	11-RRC-0200	FDA UDI	Class II	Active
Ocata Anterior Cervical System	08-CPR-0488	FDA UDI	Class II	Active
CosmoLock Pedicle Screw System	10-SNP-5545	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SCP-7515	FDA UDI	Class II	Active
Navagio	30-TNS-2709	FDA UDI	Class II	Active
TiWAVE C Cervical Cage System	20-CAT-3207	FDA UDI	Class II	Active
NIDO Pedicle Screw System	15-BSC-9530	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SNE-8555	FDA UDI	Class II	Active
Navagio	30-TNC-3610	FDA UDI	Class II	Active
TiWave C Cervical Cage System	20-CFX-7312	FDA UDI	Class II	Active
TiWave C Cervical Cage System	20-TFN-7308	FDA UDI	Class I	Active
Cosmolock Pedicle Screw System	10-SNP-8545	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-XLF-0024	FDA UDI	Class II	Active
CosmoLock Pedicle Screw System	10-SNP-5565	FDA UDI	Class II	Active
NIDO Pedicle Screw System	15-BSC-9575	FDA UDI	Class II	Active
TiWAVE C Cervical Cage System	20-CAT-5210	FDA UDI	Class II	Active
TiWAVE L Lumbar Cage System	23-LTX-2211	FDA UDI	Class I	Active
Cosmolock Pedicle Screw System	10-SST-4760	FDA UDI	Class II	Active
CosmoLock Pedicle Screw System	11-K01-1244	FDA UDI	Class I	Active
Navagio	30-TEA-3611	FDA UDI	Class II	Active
Ocata Anterior Cervical System	08-SDF-4016	FDA UDI	Class II	Active
Navagio	30-TTC-3615	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SCB-8505	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-BRC-0140	FDA UDI	Class II	Active
TiWAVE C Cervical Cage System	20-CAX-3206	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SSP-6565	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SRP-8555	FDA UDI	Class II	Active
TiWAVE C Cervical Cage System	20-TFN-5207	FDA UDI	Class I	Active
Cosmolock Pedicle Screw System	10-BRC-0070	FDA UDI	Class II	Active
Matira Anterior Cervical System	07-STF-4017	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-BRS-0075	FDA UDI	Class II	Active
TiWAVE C Cervical Cage System	20-K01-0006	FDA UDI	Class I	Active

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