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
Ocata Anterior Cervical System	08-K01-3000	FDA UDI	Class I	Active
TiWAVE C Cervical Cage System	20-CAX-3208	FDA UDI	Class II	Active
TiWave C Cervical Cage System	20-TAX-7307	FDA UDI	Class I	Active
NIDO Pedicle Screw System	15-BCC-7550	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SSP-7520	FDA UDI	Class II	Active
CosmoLock Pedicle Screw System	10-K01-31300	FDA UDI	Class I	Active
Cosmolock Pedicle Screw System	10-BRS-0150	FDA UDI	Class II	Active
InTess Lumbar Cage	12-PCT-3009	FDA UDI	Class II	Active
Cosmolock	11-RSC-0160	FDA UDI	Class II	Active
Navagio	30-PNS-2514	FDA UDI	Class II	Active
TiWAVE C Cervical Cage System	20-RAN-5206	FDA UDI	Class I	Active
Cosmolock Pedicle Screw System	10-SRE-7535	FDA UDI	Class II	Active
CosmoLock Pedicle Screw System	11-K01-4003	FDA UDI	Class I	Active
Navagio	30-TTS-3211	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SRE-7530	FDA UDI	Class II	Active
InTess C Cervical Cage System	09-K01-510T	FDA UDI	Class I	Active
Navagio	30-K01-7100	FDA UDI	Class I	Active
Cosmolock Pedicle Screw System	10-SRE-7525	FDA UDI	Class II	Active
CosmoLock Pedicle Screw System	10-SSE-5535	FDA UDI	Class II	Active
InTess C Cervical Cage System	09-K01-708T	FDA UDI	Class I	Active
TiWAVE C Cervical Cage System	20-TAN-9410	FDA UDI	Class I	Active
Kalitec Universal Instruments	01-K03-8001	FDA UDI	Class I	Active
TiWAVE L Lumbar Cage System	23-LTT-2514	FDA UDI	Class I	Active
Cosmolock	10-BRS-0230	FDA UDI	Class II	Active
TiWAVE L Lumbar Cage System	23-LCX-2510	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SNP-8560	FDA UDI	Class II	Active
Ocata Anterior Cervical System	08-CPR-0124	FDA UDI	Class II	Active
InSePtion MIS Fixation System	14-K01-1212	FDA UDI	Class I	Active
Cosmolock Pedicle Screw System	10-SCP-8555	FDA UDI	Class II	Active
InTess Lumbar Cage	12-K01-0314	FDA UDI	Class I	Active
InSePtion MIS Fixation System	14-K01-0021	FDA UDI	Class I	Active
TiWAVE C Cervical Cage System	20-CAX-3207	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SRT-6525	FDA UDI	Class II	Active
NIDO Pedicle Screw System	15-BSC-9590	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SCT-7530	FDA UDI	Class II	Active
Cosmolock	11-RSS-0055	FDA UDI	Class II	Active
TiWAVE L Lumbar Cage System	23-LCN-2016	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SCE-6530	FDA UDI	Class II	Active
Matira Anterior Cervical System	07-STF-4511	FDA UDI	Class II	Active
NIDO Pedicle Screw System	15-BCC-6535	FDA UDI	Class II	Active
Screw, Self Drilling, Variable, 4.0 x 17mm	08-SDV-4017	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SRE-6560	FDA UDI	Class II	Active
TiWAVE C Cervical Cage System	20-RFN-5212	FDA UDI	Class I	Active
InTess Lumbar Cage	12-K06-0010	FDA UDI	Class I	Active
NIDO Pedicle Screw System	15-BCC-0585	FDA UDI	Class II	Active
CosmoLock Pedicle Screw System	11-SSP-7575	FDA UDI	Class II	Active
InTess C Cervical Cage System	09-CCT-9507	FDA UDI	Class II	Active
NIDO Pedicle Screw System	15-BSC-0510	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SRT-7560	FDA UDI	Class II	Active
TiWAVE C Cervical Cage System	20-CFT-3205	FDA UDI	Class II	Active

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