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-SNE-8530	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SST-7535	FDA UDI	Class II	Active
Matira Anterior Cervical System	07-CPR-0480	FDA UDI	Class II	Active
Kalitec Disc Prep	19-K01-6090	FDA UDI	Class I	Active
TiWAVE L Lumbar Cage System	23-LCN-2014	FDA UDI	Class II	Active
Cosmolock Pedicle Scew System	10-SNP-4730	FDA UDI	Class II	Active
NIDO Pedicle Screw System	15-BCC-7515	FDA UDI	Class II	Active
NIDO Pedicle Screw System	15-BCC-0565	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SSE-6535	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SRE-8525	FDA UDI	Class II	Active
TiWAVE C Cervical Cage System	20-CFN-7307	FDA UDI	Class II	Active
CosmoLock Pedicle Screw System	10-K01-9111	FDA UDI	Class I	Active
CosmoLock Pedicle Screw System	10-K01-1530	FDA UDI	Class I	Active
InTess C Cervical Cage System	09-CCN-4107	FDA UDI	Class II	Active
TiWAVE C Cervical Cage System	20-CAX-5210	FDA UDI	Class II	Active
Navagio	30-TTC-3209	FDA UDI	Class II	Active
Navagio	30-TTA-2716	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SSP-4725	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SCE-7535	FDA UDI	Class II	Active
NIDO Pedicle Screw System	15-BCC-0580	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SST-4740	FDA UDI	Class II	Active
TiWave C Cervical Cage System	20-RFN-7309	FDA UDI	Class I	Active
Cosmolock Pedicle Screw System	10-SNP-7535	FDA UDI	Class II	Active
TiWave C Cervical Cage System	20-TAT-9407	FDA UDI	Class I	Active
TiWave C Cervical Cage System	20-CFN-6407	FDA UDI	Class II	Active
CosmoLock Pedicle Screw System	10-SCP-5550	FDA UDI	Class II	Active
Ocata Anterior Cervical System	08-CPR-0468	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SRP-4735	FDA UDI	Class II	Active
CosmoLock Pedicle Screw System	10-SRP-5545	FDA UDI	Class II	Active
Cosmolock	11-K11-0011	FDA UDI	Class I	Active
Navagio	30-TNC-3214	FDA UDI	Class II	Active
NIDO Pedicle Screw System	15-BCC-4725	FDA UDI	Class II	Active
Navagio	30-TES-2714	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-XLF-0016	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SSE-8530	FDA UDI	Class II	Active
CosmoLock Pedicle Screw System	11-RRC-0075	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SNT-7555	FDA UDI	Class II	Active
Cosmolock	11-RRC-0180	FDA UDI	Class II	Active
Navagio	30-PTS-2508	FDA UDI	Class II	Active
Kalitec Special	DR-K01-0008	FDA UDI	Class I	Active
TiWAVE L Lumbar Cage System	23-LCX-2014	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SSP-6550	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SRT-6545	FDA UDI	Class II	Active
CosmoLock Pedicle Screw System	10-SSE-5555	FDA UDI	Class II	Active
TiWAVE C Cervical Cage System	20-TFX-3205	FDA UDI	Class I	Active
Kalitec Disc Prep	19-K08-6150	FDA UDI	Class I	Active
Cosmolock	11-K01-1222	FDA UDI	Class I	Active
Cosmolock Pedicle Screw System	10-SSE-7560	FDA UDI	Class II	Active
CosmoLock Pedicle Screw System	11-K01-4000	FDA UDI	Class I	Active
CosmoLock Pedicle Screw System	11-K01-1205	FDA UDI	Class I	Active

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