Rti Surgical, Inc.

Address:1800 A North Greene Street,Greenville,NC,27834,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

TRAY, SURGICAL, INSTRUMENT (FSM) (3) Cerclage, fixation (JDQ) (3) APPLIER, CERCLAGE (HXN) (2) Plate, fixation, bone (HRS) (2) Screw, fixation, bone (HWC) (2) Intervertebral fusion device with bone graft, cervical (ODP) (1) Intervertebral fusion device with bone graft, lumbar (MAX) (1) ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (LXH) (1)

Premarket Exempt

No Yes

Clear

EVOS Cabling System - 00191083003979 Catalog Number : 72580000

Device Description : Cable Stainless Steel w/Crimp

Device Class : 2

Duns Number: 117560455

Premarket Exempt : No

Product Code : JDQ

Prescription Use : Yes

Device Count : 1

EVOS Cabling System - 00191083003986 Catalog Number : 71175667

Device Description : Cable Tensioner Nose Cone

Device Class : 1

Duns Number: 117560455

Premarket Exempt : Yes

Product Code : HXN

Prescription Use : Yes

Device Count : 1

EVOS Cabling System - 00191083003993 Catalog Number : 71175677

Device Description : Cable Crimper

Device Class : 1

Duns Number: 117560455

Premarket Exempt : Yes

Product Code : HXN

Prescription Use : Yes

Device Count : 1

EVOS Cabling System - 00191083004006 Catalog Number : 71175691

Device Description : Cable Instrument Tray

Device Class : 1

Duns Number: 117560455

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

EVOS Cabling System - 00191083004013 Catalog Number : 71175692

Device Description : Cable Instrument Tray Lid

Device Class : 1

Duns Number: 117560455

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

Tritium Sternal Cable Plate System - 00191083005522 Catalog Number : 86-250

Device Description : X Plate Without Cable

Device Class : 2

Duns Number: 117560455

Premarket Exempt : No

Product Code : JDQ, HWC, HRS

Prescription Use : Yes

Device Count : 1

Tritium Sternal Cable Plate System - 00191083005539 Catalog Number : 86-450

Device Description : Box Plate Without Cable

Device Class : 2

Duns Number: 117560455

Premarket Exempt : No

Product Code : HRS, JDQ, HWC

Prescription Use : Yes

Device Count : 1

Streamline TL Spinal Fixation System - 00191083005744 Catalog Number : 02-65-L-SCREW-CDY

Device Description : SCREW CADDY

Device Class : 1

Duns Number: 117560455

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

Streamline TL Spinal Fixation System - 00191083005751 Catalog Number : 02-RS-RET-CAP

Device Description : REDUCTION SCREW RETAINING CAP

Device Class : 1

Duns Number: 117560455

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Fortilink-C IBF System - 00191083006536 Catalog Number : 65-C-1012-10-6L

Device Description : Interbody Fusion Device

Device Class : 2

Duns Number: 117560455

Premarket Exempt : No

Product Code : MAX, ODP

Prescription Use : Yes

Device Count : 1

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