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, INSTRUMENT (FSM) (7) CERCLAGE, FIXATION (JDQ) (1) ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (LXH) (1) TEMPLATE (HWT) (1)

Premarket Exempt

No Yes

Clear

Fusion Anterior Instrument Set - 00846468099916 Catalog Number : 57-CASE-1

Device Description : INSTRUMENT CASE

Device Class : 1

Duns Number: 793384496

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

Fusion Anterior Instrument Set - 00846468099923 Catalog Number : 57-CASE-2

Device Description : INSTRUMENT CASE

Device Class : 1

Duns Number: 793384496

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

Fortilink-TS IBFSystem - 00846468099930 Catalog Number : 725-133

Device Description : FORTILINK-TS, PISTOL GRIP INSERTER

Device Class : 1

Duns Number: 793384496

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Fortilink-C IBF System - 00846468099947 Catalog Number : 65-C-TRL-M-9-6L

Device Description : Trial Spacer

Device Class : 1

Duns Number: 793384496

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : Yes

Device Count : 1

Streamline TL Spinal Fixation System - 00846468099954 Catalog Number : 02-LID-RC-LNG

Device Description : Replacement Lid, Long Rod Caddy

Device Class : 1

Duns Number: 793384496

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

Streamline TL Spinal Fixation System - 00846468099961 Catalog Number : 02-FX-AUXCDY-E

Device Description : Auxiliary Screw Caddy, Fixed, Empty

Device Class : 1

Duns Number: 793384496

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

Streamline TL Spinal Fixation System - 00846468099978 Catalog Number : 02-CASE-DEF-EMPTY2

Device Description : Instrument Case 2

Device Class : 1

Duns Number: 793384496

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

Streamline TL Spinal Fixation System - 00846468099985 Catalog Number : 02-CASE-DEF-EMPTY1

Device Description : Instrument Case 1

Device Class : 1

Duns Number: 793384496

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

Streamline TL Spinal Fixation System - 00846468099992 Catalog Number : 02-95SCREW-CDY

Device Description : SCREW CADDY

Device Class : 1

Duns Number: 793384496

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

DePuy Songer Spinal Cable System - 10846468005013 Catalog Number : 7825011

Device Description : Cable, Double, Loop, SS, w/Crmp, NS,

Device Class : 2

Duns Number: 793384496

Premarket Exempt : No

Product Code : JDQ

Prescription Use : Yes

Device Count : 1

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