SYNTEC SCIENTIFIC CORPORATION

Address:2, KUNG SAN ROAD, CHUAN SHING,CHANG HUA Changhua,TW

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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

Screw, Fixation, Bone (HWC) (9) Rod, Fixation, Intramedullary And Accessories (HSB) (1)

Premarket Exempt

No Yes

Clear

Syntec Osteo-plate and screw Fixation - 04712782854233 Catalog Number :

Device Description : Cortex Screw Self-Tappingφ3.5 x L20mm

Device Class : 2

Duns Number: 657692971

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Syntec Osteo-plate and screw Fixation - 04712782854257 Catalog Number :

Device Description : Cortex Screw Self-Tappingφ3.5 x L24mm

Device Class : 2

Duns Number: 657692971

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Syntec Osteo-plate and screw Fixation - 04712782854271 Catalog Number :

Device Description : Cortex Screw Self-Tappingφ3.5 x L28mm

Device Class : 2

Duns Number: 657692971

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Syntec Osteo-plate and screw Fixation - 04712782854295 Catalog Number :

Device Description : Cortex Screw Self-Tappingφ3.5 x L32mm

Device Class : 2

Duns Number: 657692971

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Syntec Osteo-plate and screw Fixation - 04712782854318 Catalog Number :

Device Description : Cortex Screw Self-Tappingφ3.5 x L36mm

Device Class : 2

Duns Number: 657692971

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Syntec Osteo-plate and screw Fixation - 04712782854332 Catalog Number :

Device Description : Cortex Screw Self-Tappingφ3.5 x L40mm

Device Class : 2

Duns Number: 657692971

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Syntec Osteo-plate and screw Fixation - 04712782854349 Catalog Number :

Device Description : Cortex Screw Self-Tappingφ3.5 x L45mm

Device Class : 2

Duns Number: 657692971

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Syntec Osteo-plate and screw Fixation - 04712782854356 Catalog Number :

Device Description : Cortex Screw Self-Tappingφ3.5 x L50mm

Device Class : 2

Duns Number: 657692971

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Syntec Osteo-plate and screw Fixation - 04712782854363 Catalog Number :

Device Description : Cortex Screw Self-Tappingφ3.5 x L55mm

Device Class : 2

Duns Number: 657692971

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Syntec Femoral Nail System - 04712782900022 Catalog Number :

Device Description : Syntec Femoral Nail System φ13 x L380mm

Device Class : 2

Duns Number: 657692971

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

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