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 System - 00815362020302 Catalog Number : 39-PH-8535

Device Description : 8.5 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 - 00815362020319 Catalog Number : 39-PH-8540

Device Description : 8.5 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 - 00815362020326 Catalog Number : 39-PH-8545

Device Description : 8.5 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 - 00815362020333 Catalog Number : 39-PH-8550

Device Description : 8.5 x 50mm 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 - 00815362020340 Catalog Number : 39-PH-8555

Device Description : 8.5 x 55mm 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 - 00815362020357 Catalog Number : 39-PH-8560

Device Description : 8.5 x 60mm 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 - 00815362020364 Catalog Number : 39-PH-8570

Device Description : 8.5 x 60mm 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 - 00815362020371 Catalog Number : 39-PH-8580

Device Description : 8.5 x 60mm 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 - 00815362020388 Catalog Number : 39-PH-8590

Device Description : 8.5 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 - 00815362020395 Catalog Number : 39-PH-8500

Device Description : 8.5 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

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