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

BENDER (HXW) (5) ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (LXH) (2) INSTRUMENT, BENDING OR CONTOURING (HXP) (1) ORTHOSIS, SPINAL PEDICLE FIXATION (MNI) (1) Orthosis, spinal pedicle fixation, for degenerative disc disease (NKB) (1) Orthosis, spondylolisthesis spinal fixation (MNH) (1) APPLIANCE, FIXATION, SPINAL INTERLAMINAL (KWP) (1) Wire, surgical (LRN) (1) APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY (KWQ) (1)

Premarket Exempt

No Yes

Clear

NA - 20705034711093 Catalog Number : U4464018S

Device Description : DISTRACTOR PINS-STERILE 18MM LENGTH

Device Class :

Duns Number: 832637081

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 10

NA - 20705034718351 Catalog Number : 03622060

Device Description : PIPE BENDERS WITH LONG HANDLES

Device Class :

Duns Number: 832637081

Premarket Exempt : Yes

Product Code : HXW

Prescription Use : Yes

Device Count : 2

NA - 20705034734160 Catalog Number : 0460002210S

Device Description : TI DISTRACTOR PINS-12MM STERILE

Device Class :

Duns Number: 832637081

Premarket Exempt : Yes

Product Code : HXW

Prescription Use : Yes

Device Count : 10

NA - 20705034734191 Catalog Number : 0460002310S

Device Description : TI DISTRACTOR PINS-14MM STERILE

Device Class :

Duns Number: 832637081

Premarket Exempt : Yes

Product Code : HXW

Prescription Use : Yes

Device Count : 10

NA - 20705034734214 Catalog Number : 0460002902S

Device Description : TI DISTRACTOR PINS-16MM STERILE

Device Class :

Duns Number: 832637081

Premarket Exempt : Yes

Product Code : HXW

Prescription Use : Yes

Device Count : 2

NA - 20705034734221 Catalog Number : 0460002910S

Device Description : TI DISTRACTOR PINS-16MM STERILE

Device Class :

Duns Number: 832637081

Premarket Exempt : Yes

Product Code : HXW

Prescription Use : Yes

Device Count : 10

NA - 20705034764051 Catalog Number : 292020

Device Description : 1.25MM GUIDE WIRE 200MM

Device Class :

Duns Number: 832637081

Premarket Exempt : Yes

Product Code : LRN

Prescription Use : Yes

Device Count : 10

NA - 20705034771950 Catalog Number : 388117

Device Description : PIPE ROD BENDERS

Device Class :

Duns Number: 832637081

Premarket Exempt : Yes

Product Code : HXP

Prescription Use : Yes

Device Count : 2

NA - 20705034788354 Catalog Number : 497789

Device Description : TI REPLACEMENT SETSCREWS M5 CONICAL TIP

Device Class :

Duns Number: 832637081

Premarket Exempt : No

Product Code : NKB, KWQ, KWP, MNI, MNH

Prescription Use : Yes

Device Count : 5

NA - 20886982000795 Catalog Number : E51141

Device Description : SET SCREWS FOR TRIAL HEAD

Device Class :

Duns Number: 832637081

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 5

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