HT MEDICAL, 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, Cervical (ODP) (8) Orthopedic Manual Surgical Instrument (LXH) (2)

Premarket Exempt

Clear

neoWave LS - 00818345027688 Catalog Number : N/A

Device Description : Inserter, 11-16H, Lumbar Straight

Device Class : 1

Duns Number: 080386764

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

neoWave C - 00818345027886 Catalog Number : N/A

Device Description : neoWave Cervical Cage, Domed, 15W x 12D x 5H, 7deg

Device Class : 2

Duns Number: 080386764

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

neoWave C - 00818345027893 Catalog Number : N/A

Device Description : neoWave Cervical Cage, Domed, 15W x 12D x 6H, 7deg

Device Class : 2

Duns Number: 080386764

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

neoWave C - 00818345027909 Catalog Number : N/A

Device Description : neoWave Cervical Cage, Domed, 15W x 12D x 7H, 7deg

Device Class : 2

Duns Number: 080386764

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

neoWave C - 00818345027916 Catalog Number : N/A

Device Description : neoWave Cervical Cage, Domed, 15W x 12D x 8H, 7deg

Device Class : 2

Duns Number: 080386764

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

neoWave C - 00818345027923 Catalog Number : N/A

Device Description : neoWave Cervical Cage, Domed, 15W x 12D x 9H, 7deg

Device Class : 2

Duns Number: 080386764

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

neoWave C - 00818345027930 Catalog Number : N/A

Device Description : neoWave Cervical Cage, Domed, 15W x 12D x 10H, 7deg

Device Class : 2

Duns Number: 080386764

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

neoWave C - 00818345027947 Catalog Number : N/A

Device Description : neoWave Cervical Cage, Domed, 15W x 12D x 11H, 7deg

Device Class : 2

Duns Number: 080386764

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

neoWave C - 00818345027954 Catalog Number : N/A

Device Description : neoWave Cervical Cage, Domed, 15W x 12D x 12H, 7deg

Device Class : 2

Duns Number: 080386764

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

neoWave LS - 00818345027961 Catalog Number : N/A

Device Description : Lumbar Inserter, PLIF, 7-10H

Device Class : 1

Duns Number: 080386764

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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