TENON MEDICAL, INC.

Address:104 Cooper Court,Los Gatos,CA,95032,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

Sacroiliac Joint Fixation (OUR) (10)

Premarket Exempt

Clear

Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) - B74240308050 Catalog Number : 40308-05

Device Description : 7.5mm Center Punch

Device Class : 2

Duns Number: 117014636

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) - B74240308060 Catalog Number : 40308-06

Device Description : 7.5mm Drill Guide

Device Class : 2

Duns Number: 117014636

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) - B74240308070 Catalog Number : 40308-07

Device Description : 7.5mm Location Pin

Device Class : 2

Duns Number: 117014636

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) - B74240308090 Catalog Number : 40308-09

Device Description : 7.5mm Bone Tamp Rod

Device Class : 2

Duns Number: 117014636

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) - B74240308100 Catalog Number : 40308-10

Device Description : 7.5mm Extraction Fork

Device Class : 2

Duns Number: 117014636

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) - B74240308110 Catalog Number : 40308-11

Device Description : 7.5mm Extraction Screw

Device Class : 2

Duns Number: 117014636

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) - B74240308120 Catalog Number : 40308-12

Device Description : 7.5mm Drill Stop

Device Class : 2

Duns Number: 117014636

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) - B74240308130 Catalog Number : 40308-13

Device Description : 7.5mm Drill Spacer 20mm

Device Class : 2

Duns Number: 117014636

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) - B74240308140 Catalog Number : 40308-14

Device Description : 7.5mm Drill Spacer 10mm

Device Class : 2

Duns Number: 117014636

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) - B74240308150 Catalog Number : 40308-15

Device Description : 7.5mm Drill Spacer 5mm

Device Class : 2

Duns Number: 117014636

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

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