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

Appliance, Fixation, Spinal Interlaminal (KWP) (10) Orthosis, Spinal Pedicle Fixation (MNI) (10) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (10) Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis (OSH) (10) Thoracolumbosacral Pedicle Screw System (NKB) (10)

Premarket Exempt

No Yes

Clear

Reform HA Coated Pedicle Screw - 00815362020005 Catalog Number : 39-PH-4525

Device Description : 4.5 x 25mm 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 - 00815362020012 Catalog Number : 39-PH-4530

Device Description : 4.5 x 30mm Reform HA Coated Pedicle Screw System

Device Class : 2

Duns Number: 079398589

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Reform HA Coated Pedicle Screw System - 00815362020029 Catalog Number : 39-PH-4535

Device Description : 4.5 x 35mm 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 - 00815362020036 Catalog Number : 39-PH-4540

Device Description : 4.5 x 40mm 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 - 00815362020043 Catalog Number : 39-PH-4545

Device Description : 4.5 x 45mm 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 - 00815362020050 Catalog Number : 39-PH-5525

Device Description : 5.5 x 25mm 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 - 00815362020067 Catalog Number : 39-PH-5530

Device Description : 5.5 x 30mm Reform HA Coated Pedicle Screw System

Device Class : 2

Duns Number: 079398589

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Reform HA Coated Pedicle Screw System - 00815362020074 Catalog Number : 39-PH-5535

Device Description : 5.5 x 35mm Reform HA Coated Pedicle Screw System

Device Class : 2

Duns Number: 079398589

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Reform HA Coated Pedicle Screw System - 00815362020081 Catalog Number : 39-PH-5540

Device Description : 5.5 x 40mm Reform HA Coated Pedicle Screw System

Device Class : 2

Duns Number: 079398589

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Reform HA Coated Pedicle Screw System - 00815362020098 Catalog Number : 39-PH-5545

Device Description : 5.5 x 45mm Reform HA Coated Pedicle Screw System

Device Class : 2

Duns Number: 079398589

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

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