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
Kalitec Universal Instruments	01-K06-2000	FDA UDI	Class I	Active
InTess Lumbar Cage	12-K01-0212	FDA UDI	Class I	Active
CosmoLock Pedicle Screw System	10-SNT-5565	FDA UDI	Class II	Active
Cosmolock	11-RSC-0050	FDA UDI	Class II	Active
InSePtion MIS Fixation System	14-K01-1010	FDA UDI	Class I	Active
TiWAVE L Lumbar Cage System	23-LCX-2011	FDA UDI	Class II	Active
InTess C Cervical Cage System	09-K01-109N	FDA UDI	Class I	Active
TiWAVE C Cervical Cage System	20-CAX-5205	FDA UDI	Class II	Active
TiWave C Cervical Cage System	20-CFN-5207	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SCT-6580	FDA UDI	Class II	Active
Universal	01-K04-8040	FDA UDI	Class I	Active
Matira Anterior Cervical System	07-ADD-1012	FDA UDI	Class I	Active
CosmoLock Pedicle Screw System	10-SRP-5535	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SSP-8500	FDA UDI	Class II	Active
Kalitec Special	DR-K01-0012	FDA UDI	Class I	Active
TiWAVE C Cervical Cage System	20-CFN-3212	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SNE-7550	FDA UDI	Class II	Active
Cosmolock	11-RSS-0080	FDA UDI	Class II	Active
InTess Lumbar Cage	12-K03-1054	FDA UDI	Class I	Active
InSePtion MIS Fixation System	14-K01-2050	FDA UDI	Class I	Active
Navagio	30-K01-4411	FDA UDI	Class I	Active
TiWave C Cervical Cage System	20-RFN-6412	FDA UDI	Class I	Active
NIDO Pedicle Screw System	15-BCC-6515	FDA UDI	Class II	Active
Cosmolock	11-K01-0020	FDA UDI	Class I	Active
NIDO Pedicle Screw System	15-BSC-4760	FDA UDI	Class II	Active
NIDO Pedicle Screw System	15-BSC-0595	FDA UDI	Class II	Active
NIDO Pedicle Screw System	15-BSC-6505	FDA UDI	Class II	Active
InTess Cervical Cage	09-CCT-4106	FDA UDI	Class II	Active
NIDO Pedicle Screw System	15-BCC-0545	FDA UDI	Class II	Active
NIDO Pedicle Screw System	15-BCC-8560	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	10-SRE-4745	FDA UDI	Class II	Active
TiWAVE C Cervical Cage System	20-RFT-3210	FDA UDI	Class I	Active
Cosmolock	11-K11-0010	FDA UDI	Class I	Active
InTess Lumbar Cage	12-K01-0312	FDA UDI	Class I	Active
Ocata Anterior Cervical System	08-SDF-4517	FDA UDI	Class II	Active
TiWAVE L Lumbar Cage System	23-LCT-2214	FDA UDI	Class II	Active
Navagio	30-TTS-3609	FDA UDI	Class II	Active
CosmoLock Pedicle Screw System	11-K01-1210	FDA UDI	Class I	Active
InTess C Cervical Cage System	09-K01-505T	FDA UDI	Class I	Active
InTess C Cervical Cage System	09-CCN-5206	FDA UDI	Class II	Active
Cosmolock Pedicle Screw System	11-XLF-0014	FDA UDI	Class II	Active
InTess Lumbar Cage	12-K01-0309	FDA UDI	Class I	Active
CosmoLock Pedicle Screw System	11-K01-1207	FDA UDI	Class I	Active
InTess Lumbar Cage	12-PCT-2108	FDA UDI	Class II	Active
Matira Anterior Cervical System	07-SDV-4015	FDA UDI	Class II	Active
InTess Lumbar Cage	12-PCT-3016	FDA UDI	Class II	Active
Navagio	30-TTA-3615	FDA UDI	Class II	Active
Cosmolock	11-K01-0006	FDA UDI	Class I	Active
Cosmolock Pedicle Screw System	10-SCP-6545	FDA UDI	Class II	Active
TiWave C Cervical Cage System	20-TFN-7311	FDA UDI	Class I	Active

Kalitec Direct LLC

What Kalitec Direct LLC makes

Frequently asked questions

Information

Catalogue (3532)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities