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
TiWAVE L Lumbar Cage System	23-LCN-2510	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SCB-8545	FDA UDI	Class II	Active
CosmoLock Pedicle Screw System	10-SRP-5540	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SRP-4730	FDA UDI	Class II	Active
Navagio	30-TTC-3610	FDA UDI	Class II	Active
TiWAVE C Cervical Cage System	20-CAN-9409	FDA UDI	Class II	Active
TiWAVE C Cervical Cage System	20-RFX-9408	FDA UDI	Class I	Active
Cosmolock Pedicle Screw System	10-SNP-7545	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-BRC-0045	FDA UDI	Class II	Active
Ocata Anterior Cervical System	08-K01-2003	FDA UDI	Class I	Active
InTess Cervical Cage	09-CCT-4108	FDA UDI	Class II	Active
Matira Anterior Cervical System	07-K01-0002	FDA UDI	Class I	Active
NIDO Pedicle Screw System	15-BSC-6540	FDA UDI	Class II	Active
TiWAVE C Cervical Cage System	20-RAX-3209	FDA UDI	Class I	Active
Cosmolock	11-RSC-0040	FDA UDI	Class II	Active
CosmoLock Pedicle Screw System	10-SBN-0500	FDA UDI	Class I	Active
Navagio	30-TNA-3213	FDA UDI	Class II	Active
CosmoLock Pedicle Screw System	10-SCP-5555	FDA UDI	Class II	Active
Cosmolock	11-K01-1225	FDA UDI	Class I	Active
Ocata Anterior Cervical System	08-SDF-4519	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SST-6540	FDA UDI	Class II	Active
TiWAVE L Lumbar Cage System	23-LCT-2216	FDA UDI	Class II	Active
TiWAVE C Cervical Cage System	20-RFN-3212	FDA UDI	Class I	Active
TiWave C Cervical Cage System	20-TFT-6408	FDA UDI	Class I	Active
TiWave C Cervical Cage System	20-TAN-7312	FDA UDI	Class I	Active
InTess C Cervical Cage System	09-K01-209N	FDA UDI	Class I	Active
Ocata Anterior Cervical System	08-SDF-4012	FDA UDI	Class II	Active
TiWAVE L Lumbar Cage System	23-LCT-3014	FDA UDI	Class II	Active
TiWAVE C Cervical Cage System	20-CAN-9412	FDA UDI	Class II	Active
TiWave C Cervical Cage System	20-RAT-7310	FDA UDI	Class I	Active
CosmoLock Pedicle Screw System	10-XLF-0018	FDA UDI	Class II	Active
CosmoLock Pedicle Screw System	10-SNE-5555	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SNP-7565	FDA UDI	Class II	Active
CosmoLock Pedicle Screw System	11-XLF-0032	FDA UDI	Class II	Active
Matira Anterior Cervical System	07-K01-7002	FDA UDI	Class I	Active
NIDO Pedicle Screw System	15-BSC-5525	FDA UDI	Class II	Active
TiWave C Cervical Cage System	20-RFX-6407	FDA UDI	Class I	Active
TiWave C Cervical Cage System	20-CAX-7312	FDA UDI	Class II	Active
Matira Anterior Cervical System	07-STF-4011	FDA UDI	Class II	Active
InTess C Cervical Cage System	09-K01-207T	FDA UDI	Class I	Active
Cosmolock Pedicle Screw System	10-SSE-8580	FDA UDI	Class II	Active
Navagio	30-TNS-3208	FDA UDI	Class II	Active
TiWAVE L Lumbar Cage System	23-LCN-2207	FDA UDI	Class II	Active
InTess Cervical Cage	09-CCT-4105	FDA UDI	Class II	Active
InTess C Cervical Cage System	09-CCN-5209	FDA UDI	Class II	Active
NIDO Pedicle Screw System	15-CTP-3100	FDA UDI	Class II	Active
Navagio	30-TNC-3211	FDA UDI	Class II	Active
TiWAVE L Lumbar Cage System	23-LCN-2008	FDA UDI	Class II	Active
TiWAVE L Lumbar Cage System	23-LTN-2010	FDA UDI	Class I	Active
InTess Cervical Cage	09-CCT-6409	FDA UDI	Class II	Active

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