SYNTHES (U.S.A.) LP

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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

TEMPLATE (HWT) (3) DRILL, BONE, POWERED (DZI) (2) Guide, surgical, instrument (FZX) (1) INSTRUMENT, BENDING OR CONTOURING (HXP) (1) BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL (GFA) (1) Instrument, surgical, orthopedic, pneumatic powered & accessory/attachment (HSZ) (1) ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (LXH) (1) PLATE, BONE (JEY) (1) INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT (HWE) (1) BUR, SURGICAL, GENERAL & PLASTIC SURGERY (GFF) (1)

Premarket Exempt

No Yes

Clear

NA - 10887587038520 Catalog Number : 317432

Device Description : 1.5MM DRILL BIT/UNIVERSAL-HALL 85MM

Device Class : 1

Duns Number: 832637081

Premarket Exempt : Yes

Product Code : GFA, HWE, GFF, HSZ

Prescription Use : Yes

Device Count : 1

NA - 10887587038568 Catalog Number : 317455

Device Description : 2.0MM DRILL BIT STRYKER J-LATCH/100MM

Device Class : 2

Duns Number: 832637081

Premarket Exempt : No

Product Code : DZI

Prescription Use : Yes

Device Count : 1

NA - 10887587038889 Catalog Number : 317832

Device Description : 1.5MM DRILL BIT/UNIVERSAL-HALL 110MM

Device Class : 2

Duns Number: 832637081

Premarket Exempt : No

Product Code : DZI

Prescription Use : Yes

Device Count : 1

NA - 10887587039305 Catalog Number : 32937

Device Description : BENDING IRON FOR 2.4MM TI UNIVERSAL & RECON PLATES

Device Class : 1

Duns Number: 832637081

Premarket Exempt : Yes

Product Code : HXP

Prescription Use : Yes

Device Count : 1

NA - 10887587039312 Catalog Number : 329399

Device Description : DISTRACTOR REMOVAL INSTRUMENT

Device Class : 1

Duns Number: 832637081

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

NA - 10887587039435 Catalog Number : 329444

Device Description : BENDING TEMPLATE FOR 1.5MM RESORBABLE DOUBLE Y-PLATE

Device Class : 1

Duns Number: 832637081

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : Yes

Device Count : 1

NA - 10887587039893 Catalog Number : 338761

Device Description : 2.4MM THREADED DRILL GUIDE

Device Class : 1

Duns Number: 832637081

Premarket Exempt : Yes

Product Code : FZX

Prescription Use : Yes

Device Count : 1

NA - 10887587039954 Catalog Number : 34644

Device Description : BENDING TEMPLATE FOR 1.5MM TI MEDIAL WALL PLATES

Device Class : 1

Duns Number: 832637081

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : Yes

Device Count : 1

NA - 10887587040073 Catalog Number : 34768

Device Description : BENDING TEMPLATE FOR 2.0MM TI DOUBLE Y-PLATE

Device Class : 1

Duns Number: 832637081

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : Yes

Device Count : 1

DCP - 10887587051024 Catalog Number : 44354

Device Description : 2.0MM TI MF DCP® PLATE 4 HOLES/22MM

Device Class : 2

Duns Number: 832637081

Premarket Exempt : Yes

Product Code : JEY

Prescription Use : Yes

Device Count : 1

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