PRECISION SPINE, INC.

Address:2050 Executive Dr,Pearl,MS,39208,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

Intervertebral Fusion Device With Bone Graft, Cervical (ODP) (6) Appliance, Fixation, Spinal Interlaminal (KWP) (4) Orthosis, Spinal Pedicle Fixation (MNI) (4) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (4) Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis (OSH) (4) Thoracolumbosacral Pedicle Screw System (NKB) (4)

Premarket Exempt

No Yes

Clear

Reform HA Coated Pedicle Screw System - 00815362020609 Catalog Number : 39-PH-1090

Device Description : 10.5 x 90mm Reform HA Coated Pedicle Screw System

Device Class : 2

Duns Number: 079398589

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Reform HA Coated Pedicle Screw System - 00815362020616 Catalog Number : 39-PH-1000

Device Description : 10.5 x 100mm Reform HA Coated Pedicle Screw System

Device Class : 2

Duns Number: 079398589

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Reform HA Coated Pedicle Screw System - 00815362020623 Catalog Number : 39-PH-1011

Device Description : 10.5 x 110mm Reform HA Coated Pedicle Screw System

Device Class : 2

Duns Number: 079398589

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Reform HA Coated Pedicle Screw System - 00815362020630 Catalog Number : 39-PH-1012

Device Description : 10.5 x 120mm Reform HA Coated Pedicle Screw System

Device Class : 2

Duns Number: 079398589

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

ShurFit ACIF 2C - 00815362020647 Catalog Number : ACIF05-05P-2C

Device Description : CpTi + HA Coated ACIF Cage Peek 05 degree x 5mm

Device Class : 2

Duns Number: 079398589

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

ShurFit ACIF 2C - 00815362020654 Catalog Number : ACIF05-06P-2C

Device Description : CpTi + HA Coated ACIF Cage Peek 05 degree x 6mm

Device Class : 2

Duns Number: 079398589

Premarket Exempt : No

Product Code : ODP

Prescription Use : No

Device Count : 1

ShurFit ACIF 2C - 00815362020661 Catalog Number : ACIF05-07P-2C

Device Description : CpTi + HA Coated ACIF Cage Peek 05 degree x 7mm

Device Class : 2

Duns Number: 079398589

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

ShurFit ACIF 2C - 00815362020678 Catalog Number : ACIF05-08P-2C

Device Description : CpTi + HA Coated ACIF Cage Peek 05 degree x 8mm

Device Class : 2

Duns Number: 079398589

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

ShurFit ACIF 2C - 00815362020685 Catalog Number : ACIF05-09P-2C

Device Description : CpTi + HA Coated ACIF Cage Peek 05 degree x 9mm

Device Class : 2

Duns Number: 079398589

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

ShurFit ACIF 2C - 00815362020692 Catalog Number : ACIF05-10P-2C

Device Description : CpTi + HA Coated ACIF Cage Peek 05 degree x 10mm

Device Class : 2

Duns Number: 079398589

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

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