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) (9) Intervertebral Fusion Device With Bone Graft, Cervical (ODP) (1)

Premarket Exempt

No Yes

Clear

Navagio - B07330TTS36090 Catalog Number : 30-TTS-3609

Device Description : Lumbar Cage, 36x9mm 7-Degree STR

Device Class : 2

Duns Number: 041956211

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Navagio - B07330TTS36100 Catalog Number : 30-TTS-3610

Device Description : Lumbar Cage, 36x10mm 7-Degree STR

Device Class : 2

Duns Number: 041956211

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Navagio - B07330TTS36110 Catalog Number : 30-TTS-3611

Device Description : Lumbar Cage, 36x11mm 7-Degree STR

Device Class : 2

Duns Number: 041956211

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Navagio - B07330TTS36120 Catalog Number : 30-TTS-3612

Device Description : Lumbar Cage, 36x12mm 7-Degree STR

Device Class : 2

Duns Number: 041956211

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Navagio - B07330TTS36130 Catalog Number : 30-TTS-3613

Device Description : Lumbar Cage, 36x13mm 7-Degree STR

Device Class : 2

Duns Number: 041956211

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Navagio - B07330TTS36140 Catalog Number : 30-TTS-3614

Device Description : Lumbar Cage, 36x14mm 7-Degree STR

Device Class : 2

Duns Number: 041956211

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Navagio - B07330TTS36150 Catalog Number : 30-TTS-3615

Device Description : Lumbar Cage, 36x15mm 7-Degree STR

Device Class : 2

Duns Number: 041956211

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Navagio - B07330TTS36160 Catalog Number : 30-TTS-3616

Device Description : Lumbar Cage, 36x16mm 7-Degree STR

Device Class : 2

Duns Number: 041956211

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Navagio - B073330TTC36100 Catalog Number : 30-TTC-3610

Device Description : Lumbar Cage, 36x10mm 7-Degree OB CRV

Device Class : 2

Duns Number: 041956211

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

InTess C Cervical Cage System - B07390CCT95100 Catalog Number :

Device Description : Cervical Cage, 19 x 15, 10mm, 7 Degree, Tapered

Device Class : 2

Duns Number: 041956211

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

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