Kalitec Direct LLC

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Intervertebral Fusion Device With Bone Graft, Lumbar (MAX) (10)

Premarket Exempt

No Yes

Clear

Navagio - B07330TTC36130 Catalog Number : 30-TTC-3613

Device Description : Lumbar Cage, 36x13mm 7-Degree OB CRV

Device Class : 2

Duns Number: 041956211

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Navagio - B07330TTC36140 Catalog Number : 30-TTC-3614

Device Description : Lumbar Cage, 36x14mm 7-Degree OB CRV

Device Class : 2

Duns Number: 041956211

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Navagio - B07330TTC36150 Catalog Number : 30-TTC-3615

Device Description : Lumbar Cage, 36x15mm 7-Degree OB CRV

Device Class : 2

Duns Number: 041956211

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Navagio - B07330TTC36160 Catalog Number : 30-TTC-3616

Device Description : Lumbar Cage, 36x16mm 7-Degree OB CRV

Device Class : 2

Duns Number: 041956211

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Navagio - B07330TTS27080 Catalog Number : 30-TTS-2708

Device Description : Lumbar Cage, 27x8mm 7-Degree STR

Device Class : 2

Duns Number: 041956211

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Navagio - B07330TTS27090 Catalog Number : 30-TTS-2709

Device Description : Lumbar Cage, 27x9mm 7-Degree STR

Device Class : 2

Duns Number: 041956211

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Navagio - B07330TTS27100 Catalog Number : 30-TTS-2710

Device Description : Lumbar Cage, 27x10mm 7-Degree STR

Device Class : 2

Duns Number: 041956211

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Navagio - B07330TTS27110 Catalog Number : 30-TTS-2711

Device Description : Lumbar Cage, 27x11mm 7-Degree STR

Device Class : 2

Duns Number: 041956211

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Navagio - B07330TTS27120 Catalog Number : 30-TTS-2712

Device Description : Lumbar Cage, 27x12mm 7-Degree STR

Device Class : 2

Duns Number: 041956211

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Navagio - B07330TTS27130 Catalog Number : 30-TTS-2713

Device Description : Lumbar Cage, 27x13mm 7-Degree STR

Device Class : 2

Duns Number: 041956211

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

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