ZAVATION LLC

Address:3670 Flowood Dr,Flowood,MS,39232,US

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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

Appliance, Fixation, Spinal Intervertebral Body (KWQ) (4) Intervertebral Fusion Device With Integrated Fixation, Lumbar (OVD) (2) Spinal Vertebral Body Replacement Device (MQP) (2) Spinal Vertebral Body Replacement Device - Cervical (PLR) (2) Sacroiliac Joint Fixation (OUR) (1) Intervertebral Fusion Device With Integrated Fixation, Cervical (OVE) (1) Screw, Fixation, Bone (HWC) (1)

Premarket Exempt

No Yes

Clear

Zavation - 00842166195028 Catalog Number :

Device Description : Z-Link Lumbar Tray

Device Class : 2

Duns Number: 069472800

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Zavation - 00842166195035 Catalog Number :

Device Description : Z-Span Anterior System Tray

Device Class : 2

Duns Number: 069472800

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Zavation - 00842166195042 Catalog Number :

Device Description : Z-Span Lateral System Tray

Device Class : 2

Duns Number: 069472800

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Zavation - 00842166195059 Catalog Number :

Device Description : EZ Plate Cervical Tray

Device Class : 2

Duns Number: 069472800

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Zavation - 00842166195066 Catalog Number :

Device Description : Normandy VBR System Tray

Device Class : 2

Duns Number: 069472800

Premarket Exempt : No

Product Code : MQP, PLR

Prescription Use : Yes

Device Count : 1

Zavation - 00842166195073 Catalog Number :

Device Description : Z-Direct Instrument Tray

Device Class : 2

Duns Number: 069472800

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Zavation - 00842166195080 Catalog Number :

Device Description : 1-2 Level Cervical Plate Tray

Device Class : 2

Duns Number: 069472800

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Zavation - 00842166195097 Catalog Number :

Device Description : SI Screw Tray

Device Class : 2

Duns Number: 069472800

Premarket Exempt : No

Product Code : HWC, OUR

Prescription Use : Yes

Device Count : 1

Zavation - 00842166195103 Catalog Number :

Device Description : Normandy Set Screw Caddy

Device Class : 2

Duns Number: 069472800

Premarket Exempt : No

Product Code : PLR, MQP

Prescription Use : Yes

Device Count : 1

Zavation - 00842166195110 Catalog Number :

Device Description : Z-Link Cervical Tray

Device Class : 2

Duns Number: 069472800

Premarket Exempt : No

Product Code : OVE

Prescription Use : Yes

Device Count : 1

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