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

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (LXH) (7) Intervertebral fusion device with bone graft, cervical (ODP) (2) Intervertebral fusion device with bone graft, lumbar (MAX) (2) FORK (HXE) (1) Spinal vertebral body replacement device (MQP) (1)

Premarket Exempt

No Yes

Clear

Cross-Fuse® II PEEK IBF System - 00191083032085 Catalog Number : 38-2660-9-6L

Device Description : INTERBODY FUSION DEVICE

Device Class : 2

Duns Number: 793384496

Premarket Exempt : No

Product Code : ODP, MAX, MQP

Prescription Use : Yes

Device Count : 1

Cross-Fuse® II PEEK IBF System - 00191083033174 Catalog Number : 38-FORK-14

Device Description : IMPLANT FORK

Device Class : 1

Duns Number: 793384496

Premarket Exempt : Yes

Product Code : HXE

Prescription Use : Yes

Device Count : 1

Cross-Fuse® PEEK IBF System - 00191083033686 Catalog Number : 35-CASE

Device Description : INSTRUMENT CASE

Device Class : 2

Duns Number: 793384496

Premarket Exempt : No

Product Code : ODP, MAX

Prescription Use : Yes

Device Count : 1

Streamline OCT Occipito-Cervico-Thoracic System - 00846468000011 Catalog Number : 724-983

Device Description : STREAMLINE OCT, RIGID SCREW INSERTER

Device Class : 1

Duns Number: 793384496

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

FORTILINK-L IBF SYSTEM - 00846468000028 Catalog Number : 65-L-FORK2-14

Device Description : Inserter Fork, 14mm

Device Class : 1

Duns Number: 793384496

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

FORTILINK-L IBF SYSTEM - 00846468000035 Catalog Number : 65-L-FORK2-18

Device Description : Inserter Fork, 18mm

Device Class : 1

Duns Number: 793384496

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

FORTILINK-L IBF SYSTEM - 00846468000042 Catalog Number : 65-L-FORK2-22

Device Description : Inserter Fork, 22mm

Device Class : 1

Duns Number: 793384496

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

FORTILINK-L IBF SYSTEM - 00846468000059 Catalog Number : 65-L-FORK2-26

Device Description : Inserter Fork, 26mm

Device Class : 1

Duns Number: 793384496

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

FORTILINK-L IBF SYSTEM - 00846468000066 Catalog Number : 65-L-INSERTER2

Device Description : Inserter

Device Class : 1

Duns Number: 793384496

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Fortilink-TS IBF System - 00846468000073 Catalog Number : 724-971

Device Description : FORTILINK-TS, INSERTER, DEPTH MARKINGS

Device Class : 1

Duns Number: 793384496

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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