CORELINK LLC

Address:2072 Fenton Logistics Park Blvd,Fenton,MO,63026,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) (10)

Premarket Exempt

Clear

ZOU Plate System - M72510000015 Catalog Number : 10000-015

Device Description : ANTERIOR LUMBAR PLATE - ZOU - 15MM

Device Class : 2

Duns Number: 064191453

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

ZOU Plate System - M72510000017 Catalog Number : 10000-017

Device Description : ANTERIOR LUMBAR PLATE - ZOU - 17MM

Device Class : 2

Duns Number: 064191453

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

ZOU Plate System - M72510000019 Catalog Number : 10000-019

Device Description : ANTERIOR LUMBAR PLATE - ZOU - 19MM

Device Class : 2

Duns Number: 064191453

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

ZOU Plate System - M72510000021 Catalog Number : 10000-021

Device Description : ANTERIOR LUMBAR PLATE - ZOU - 21MM

Device Class : 2

Duns Number: 064191453

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

ZOU Plate System - M72510000023 Catalog Number : 10000-023

Device Description : ANTERIOR LUMBAR PLATE - ZOU - 23MM

Device Class : 2

Duns Number: 064191453

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

ZOU Plate System - M72510000025 Catalog Number : 10000-025

Device Description : ANTERIOR LUMBAR PLATE - ZOU - 25MM

Device Class : 2

Duns Number: 064191453

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

ZOU Plate System - M7251015521 Catalog Number : 10155-21

Device Description : ANTERIOR LUMBAR SCREW - 5.5MM X 21MM

Device Class : 2

Duns Number: 064191453

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

ZOU Plate System - M7251015524 Catalog Number : 10155-24

Device Description : ANTERIOR LUMBAR SCREW - 5.5MM X 24MM

Device Class : 2

Duns Number: 064191453

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

ZOU Plate System - M7251015528 Catalog Number : 10155-28

Device Description : ANTERIOR LUMBAR SCREW - 5.5MM X 28MM

Device Class : 2

Duns Number: 064191453

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

ZOU Plate System - M7251015532 Catalog Number : 10155-32

Device Description : ANTERIOR LUMBAR SCREW - 5.5MM X 32MM

Device Class : 2

Duns Number: 064191453

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

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