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

Premarket Exempt

Clear

NA - 00841379199410 Catalog Number : GA245508A

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 - 00841379199427 Catalog Number : GA245508B

Device Description : LLIF SPACER

Device Class : 2

Duns Number: 073029645

Premarket Exempt : No

Product Code : KWQ, MAX, OVD

Prescription Use : Yes

Device Count : 1

N/A - 00841379199434 Catalog Number : GZB13SY05

Device Description : LLIF CUP CURETTE, UP PULLING, SERRATED

Device Class : 2

Duns Number: 073029645

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

NA - 00841379199441 Catalog Number : GA245510A

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 - 00841379199458 Catalog Number : GA245510B

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 - 00841379199465 Catalog Number : GA245510C

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 - 00841379199472 Catalog Number : GA245510D

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 - 00841379199489 Catalog Number : GA245512A

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 - 00841379199496 Catalog Number : GA245512B

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 - 00841379199502 Catalog Number : GA245512C

Device Description : LLIF SPACER

Device Class : 2

Duns Number: 073029645

Premarket Exempt : No

Product Code : KWQ, MAX, OVD

Prescription Use : Yes

Device Count : 1

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