HYHTE HOLDINGS, INC.

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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) (9) Intervertebral Fusion Device With Bone Graft, Lumbar (MAX) (9) Intervertebral Fusion Device With Integrated Fixation, Lumbar (OVD) (9)

Premarket Exempt

Clear

NA - 00841379199915 Catalog Number : GA246012C

Device Description : LLIF SPACER

Device Class : 2

Duns Number: 073029645

Premarket Exempt : No

Product Code : KWQ, MAX, OVD

Prescription Use : Yes

Device Count : 1

NA - 00841379199922 Catalog Number : GA246012D

Device Description : LLIF SPACER

Device Class : 2

Duns Number: 073029645

Premarket Exempt : No

Product Code : KWQ, MAX, OVD

Prescription Use : Yes

Device Count : 1

NA - 00841379199939 Catalog Number : GA246014A

Device Description : LLIF SPACER

Device Class : 2

Duns Number: 073029645

Premarket Exempt : No

Product Code : MAX, OVD, KWQ

Prescription Use : Yes

Device Count : 1

NA - 00841379199946 Catalog Number : GA246014B

Device Description : LLIF SPACER

Device Class : 2

Duns Number: 073029645

Premarket Exempt : No

Product Code : MAX, OVD, KWQ

Prescription Use : Yes

Device Count : 1

NA - 00841379199953 Catalog Number : GA246014C

Device Description : LLIF SPACER

Device Class : 2

Duns Number: 073029645

Premarket Exempt : No

Product Code : MAX, OVD, KWQ

Prescription Use : Yes

Device Count : 1

NA - 00841379199960 Catalog Number : GA246014D

Device Description : LLIF SPACER

Device Class : 2

Duns Number: 073029645

Premarket Exempt : No

Product Code : MAX, OVD, KWQ

Prescription Use : Yes

Device Count : 1

NA - 00841379199977 Catalog Number : GA246016A

Device Description : LLIF SPACER

Device Class : 2

Duns Number: 073029645

Premarket Exempt : No

Product Code : MAX, OVD, KWQ

Prescription Use : Yes

Device Count : 1

NA - 00841379199984 Catalog Number : GA246016B

Device Description : LLIF SPACER

Device Class : 2

Duns Number: 073029645

Premarket Exempt : No

Product Code : MAX, OVD, KWQ

Prescription Use : Yes

Device Count : 1

NA - 00841379199991 Catalog Number : GA246016C

Device Description : LLIF SPACER

Device Class : 2

Duns Number: 073029645

Premarket Exempt : No

Product Code : MAX, OVD, KWQ

Prescription Use : Yes

Device Count : 1

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