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™ SIJ Fusion System - 00850033676105 Catalog Number : 40332

Device Description : Temporary Pin 10mm, Catamaran

Device Class : 2

Duns Number: 117014636

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

CATAMARAN™ SIJ Fusion System - 00850033676112 Catalog Number : 40334

Device Description : Inserter 10mm, Catamaran

Device Class : 2

Duns Number: 117014636

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

CATAMARAN™ SIJ Fusion System - 00850033676129 Catalog Number : 40336

Device Description : Inserter Screw 10mm, Catamaran

Device Class : 2

Duns Number: 117014636

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

CATAMARAN™ SIJ Fusion System - 00850033676136 Catalog Number : 40338

Device Description : Hex Key 4mm, Catamaran

Device Class : 2

Duns Number: 117014636

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

CATAMARAN™ SIJ Fusion System - 00850033676143 Catalog Number : 40340

Device Description : Funnel Tube 10mm, Catamaran

Device Class : 2

Duns Number: 117014636

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

CATAMARAN™ SIJ Fusion System - 00850033676150 Catalog Number : 40342

Device Description : Funnel Cone 10mm, Catamaran

Device Class : 2

Duns Number: 117014636

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

CATAMARAN™ SIJ Fusion System - 00850033676167 Catalog Number : 40344

Device Description : Bone Pusher Head 10mm, Catamaran

Device Class : 2

Duns Number: 117014636

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

CATAMARAN™ SIJ Fusion System - 00850033676174 Catalog Number : 40346

Device Description : Bone Pusher Rod 10mm, Catamaran

Device Class : 2

Duns Number: 117014636

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

CATAMARAN™ SIJ Fusion System - 00850033676181 Catalog Number : 40348

Device Description : Extraction Fork 10mm, Catamaran

Device Class : 2

Duns Number: 117014636

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

CATAMARAN™ SIJ Fusion System - 00850033676198 Catalog Number : 40350

Device Description : Extraction Screw, 10mm, Catamaran

Device Class : 2

Duns Number: 117014636

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

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