Pioneer Surgical Technology, Inc.

Address:375 RIVER PARK CIRCLE,Marquette,MI,49855,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 (LRP) (6) ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (LXH) (4) Thoracolumbosacral pedicle screw system (NKB) (1)

Premarket Exempt

No Yes

Clear

Streamline TL Spinal Fixation System - 00846468000097 Catalog Number : 724-986

Device Description : STREAMLINE TL, COMPRESSOR, STRAIGHT TIP

Device Class : 1

Duns Number: 793384496

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Streamline TL Spinal Fixation System - 00846468000103 Catalog Number : 724-987

Device Description : STREAMLINE TL, DISTRACTOR, STRAIGHT TIP

Device Class : 1

Duns Number: 793384496

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

CervAlign Anterior Cervical Plate System - 00846468000110 Catalog Number : 66-1LVL-PLATE-CAD

Device Description : 1-LVL PLATE CADDY

Device Class : 1

Duns Number: 793384496

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : Yes

Device Count : 1

CervAlign Anterior Cervical Plate System - 00846468000127 Catalog Number : 66-2LVL-PLATE-CAD

Device Description : 2-LVL PLATE CADDY

Device Class : 1

Duns Number: 793384496

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : Yes

Device Count : 1

FORTILINK-L IBF SYSTEM - 00846468000134 Catalog Number : 65-L-INSERTER-A

Device Description : Angled Inserter

Device Class : 1

Duns Number: 793384496

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Quantum Spinal Fixation System - 00846468000165 Catalog Number : 724-980

Device Description : QSRS, PEDICLE SCREW INSRTR, HUSDON DRIVE

Device Class : 1

Duns Number: 793384496

Premarket Exempt : Yes

Product Code : LXH, NKB

Prescription Use : Yes

Device Count : 1

CervAlign Anterior Cervical Plate System - 00846468000172 Catalog Number : 66-3LVL-PLATE-CAD

Device Description : 3-LVL PLATE CADDY

Device Class : 1

Duns Number: 793384496

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : Yes

Device Count : 1

CervAlign Anterior Cervical Plate System - 00846468000189 Catalog Number : 66-4LVL-PLATE-CAD

Device Description : 4-LVL PLATE CADDY

Device Class : 1

Duns Number: 793384496

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : Yes

Device Count : 1

CervAlign Anterior Cervical Plate System - 00846468000196 Catalog Number : 66-5LVL-PLATE-CAD

Device Description : 5-LVL PLATE CADDY

Device Class : 1

Duns Number: 793384496

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : Yes

Device Count : 1

CervAlign Anterior Cervical Plate System - 00846468000202 Catalog Number : 66-SCREW-CADDY

Device Description : SCREW CADDY

Device Class : 1

Duns Number: 793384496

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : Yes

Device Count : 1

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