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) (3) Template (HWT) (3) Orthopedic Manual Surgical Instrument (LXH) (2) Rasp (HTR) (2)

Premarket Exempt

No Yes

Clear

TiWAVE C Cervical Cage System - B0320TFX32060 Catalog Number :

Device Description : Cervical trial, flat, 13mm x 12mm, 6mm, 14 degree, extra tapered

Device Class : 1

Duns Number: 041956211

Premarket Exempt : No

Product Code : HWT

Prescription Use : Yes

Device Count : 1

TiWAVE C Cervical Cage System - B03720RAN32070 Catalog Number :

Device Description : Cervical rasp, anatomic, 13mm x 12mm, 7mm, 0 degree, no taper

Device Class : 1

Duns Number: 041956211

Premarket Exempt : No

Product Code : HTR

Prescription Use : Yes

Device Count : 1

TiWAVE C Cervical Cage System - B03720RAN32080 Catalog Number :

Device Description : Cervical rasp, anatomic, 13mm x 12mm, 8mm, 0 degree, no taper

Device Class : 1

Duns Number: 041956211

Premarket Exempt : No

Product Code : HTR

Prescription Use : Yes

Device Count : 1

TiWAVE C Cervical Cage System - B03720TFX32080 Catalog Number :

Device Description : Cervical trial, flat, 13mm x 12mm, 8mm, 14 degree, extra tapered

Device Class : 1

Duns Number: 041956211

Premarket Exempt : No

Product Code : HWT

Prescription Use : Yes

Device Count : 1

TiWAVE C Cervical Cage System - B03720TFX52050 Catalog Number :

Device Description : Cervical trial, flat, 15mm x 12mm, 5mm, 14 degree, extra tapered

Device Class : 1

Duns Number: 041956211

Premarket Exempt : No

Product Code : HWT

Prescription Use : Yes

Device Count : 1

Navagio - B03730PTS25140 Catalog Number : 30-PTS-2514

Device Description : Lumbar Cage, 25x14mm 7-Degree STR

Device Class : 2

Duns Number: 041956211

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Navagio - B03730TNS27120 Catalog Number : 30-TNS-2712

Device Description : Lumbar Cage, 27x12mm 0-Degree STR

Device Class : 2

Duns Number: 041956211

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Navagio - B03730TS32110 Catalog Number : 30-TTS-3211

Device Description : Lumbar Cage, 32x11mm 7-Degree STR

Device Class : 2

Duns Number: 041956211

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Kalitec Universal Instruments - B07301K0160270 Catalog Number : 01-K06-6027

Device Description : Driver Shaft, Universal Removal, T27

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Kalitec Universal Instruments - B07301K0180320 Catalog Number : 01-K01-8032

Device Description : Handle, Universal Inline, Double End, M3

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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