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
Maira Anterior Cervical System	07-K01-7310	FDA UDI	Class I	Active
Navagio	30-TEC-3610	FDA UDI	Class II	Active
Ocata Anterior Cervical System	08-STF-4511	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SNT-7525	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SCE-7545	FDA UDI	Class II	Active
NIDO Pedicle Screw System	15-BSC-0535	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SNP-6550	FDA UDI	Class II	Active
TiWave C Cervical Cage System	20-TFN-6409	FDA UDI	Class I	Active
Cosmolock Pedicle Screw System	10-SST-4765	FDA UDI	Class II	Active
Ocata Anterior Cervical System	08-K01-0001	FDA UDI	Class I	Active
NIDO Pedicle Screw System	15-K11-0009	FDA UDI	Class I	Active
NIDO Pedicle Screw System	15-BSC-7550	FDA UDI	Class II	Active
TiWave C Cervical Cage System	20-CFX-5212	FDA UDI	Class II	Active
Kalitec Special	DR-K01-0004	FDA UDI	Class I	Active
TiWAVE L Lumbar Cage System	23-LTX-3009	FDA UDI	Class I	Active
Navagio	30-TEC-2709	FDA UDI	Class II	Active
TiWAVE L Lumbar Cage System	23-LTT-2007	FDA UDI	Class I	Active
TiWAVE L Lumbar Cage System	23-LTT-2811	FDA UDI	Class I	Active
TiWAVE L Lumbar Cage System	23-K01-0107	FDA UDI	Class I	Active
Cosmolock Pedicle Screw System	10-BRS-0250	FDA UDI	Class II	Active
TiWave C Cervical Cage System	20-TFX-7311	FDA UDI	Class I	Active
Navagio	30-K01-4416	FDA UDI	Class I	Active
TiWAVE C Cervical Cage Sytem	20-RFT-3212	FDA UDI	Class I	Active
NIDO Pedicle Screw System	15-K01-6000	FDA UDI	Class I	Active
TiWAVE C Cervical Cage System	20-CFX-9409	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SRE-6535	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SRE-8540	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-BRC-0130	FDA UDI	Class II	Active
Matira Anterior Cervical System	07-K01-7320	FDA UDI	Class I	Active
Cosmolock Pedicle Screw System	10-SCT-8550	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SCP-4745	FDA UDI	Class II	Active
NIDO Pedicle Screw System	15-BCC-9545	FDA UDI	Class II	Active
Matira Anterior Cervical System	07-K01-5506	FDA UDI	Class I	Active
CosmoLock Pedicle Screw System	11-RRC-0100	FDA UDI	Class II	Active
TiWAVE L Lumbar Cage System	23-LCN-2513	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-BRC-0065	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SNE-6565	FDA UDI	Class II	Active
TiWAVE L Lumbar Cage System	23-LTX-2816	FDA UDI	Class I	Active
Kalitec Special	DR-K01-0020	FDA UDI	Class I	Active
InTess C Cervical Cage System	09-CCN-9510	FDA UDI	Class II	Active
NIDO Pedicle Screw System	15-BCC-7535	FDA UDI	Class II	Active
TiWave C Cervical Cage System	20-TAN-6410	FDA UDI	Class I	Active
Navagio	30-TEA-3209	FDA UDI	Class II	Active
NIDO Pedicle Screw System	15-BSC-8550	FDA UDI	Class II	Active
TiWAVE L Lumbar Cage System	23-LTT-2508	FDA UDI	Class I	Active
Cosmolock Pedicle Screw System	10-BRS-0070	FDA UDI	Class II	Active
InTess Cervical Cage	09-CCT-4109	FDA UDI	Class II	Active
TiWAVE C Cervical Cage System	20-TFN-9410	FDA UDI	Class I	Active
Cosmolock Pedicle Screw System	10-SSE-4730	FDA UDI	Class II	Active
TiWAVE C Cervical Cage System	20-RAN-3205	FDA UDI	Class I	Active

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