Reform Ti HA Coated Pedicle Screw 39-HTC-8540

GUDID 00840019957212

Ø8.5 x 40mm Bone Screw, Cannulated

PRECISION SPINE, INC.

Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 00840019957212
• NIH Device Record Key: b8a05572-e664-4c42-8f94-69c00b08ef2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reform Ti HA Coated Pedicle Screw
• Version Model Number: 39-HTC-8540
• Catalog Number: 39-HTC-8540
• Company DUNS: 079398589
• Company Name: PRECISION SPINE, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840019957212 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151422

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-29
• Device Publish Date: 2022-07-21

On-Brand Devices [Reform Ti HA Coated Pedicle Screw]

• 00815362029817: 10.5 x 120mm Reform Ti HA Coated Pedicle Screw
• 00815362029800: 10.5 x 110mm Reform Ti HA Coated Pedicle Screw
• 00815362029794: 10.5 x 100mm Reform Ti HA Coated Pedicle Screw
• 00815362029787: 10.5 x 90mm Reform Ti HA Coated Pedicle Screw
• 00815362029770: 10.5 x 80mm Reform Ti HA Coated Pedicle Screw
• 00815362029763: 10.5 x 70mm Reform Ti HA Coated Pedicle Screw
• 00815362029756: 10.5 x 60mm Reform Ti HA Coated Pedicle Screw
• 00815362029749: 10.5 x 55mm Reform Ti HA Coated Pedicle Screw
• 00815362029732: 10.5 x 50mm Reform Ti HA Coated Pedicle Screw
• 00815362029725: 10.5 x 45mm Reform Ti HA Coated Pedicle Screw
• 00815362029718: 10.5 x 40mm Reform Ti HA Coated Pedicle Screw
• 00815362029497: 9.5 x 120mm Reform Ti HA Coated Pedicle Screw
• 00815362029480: 9.5 x 110mm Reform Ti HA Coated Pedicle Screw
• 00815362029473: 9.5 x 100mm Reform Ti HA Coated Pedicle Screw
• 00815362029466: 9.5 x 90mm Reform Ti HA Coated Pedicle Screw
• 00815362029459: 9.5 x 80mm Reform Ti HA Coated Pedicle Screw
• 00815362029442: 9.5 x 70mm Reform Ti HA Coated Pedicle Screw
• 00815362029435: 9.5 x 60mm Reform Ti HA Coated Pedicle Screw
• 00815362029428: 9.5 x 55mm Reform Ti HA Coated Pedicle Screw
• 00815362029411: 9.5 x 50mm Reform Ti HA Coated Pedicle Screw
• 00815362029404: 9.5 x 45mm Reform Ti HA Coated Pedicle Screw
• 00815362029398: 9.5 x 40mm Reform Ti HA Coated Pedicle Screw
• 00815362029381: 8.5 x 120mm Reform Ti HA Coated Pedicle Screw
• 00815362029374: 8.5 x 110mm Reform Ti HA Coated Pedicle Screw
• 00815362029367: 8.5 x 100mm Reform Ti HA Coated Pedicle Screw
• 00815362029350: 8.5 x 90mm Reform Ti HA Coated Pedicle Screw
• 00815362029343: 8.5 x 80mm Reform Ti HA Coated Pedicle Screw
• 00815362029336: 8.5 x 70mm Reform Ti HA Coated Pedicle Screw
• 00815362029329: 8.5 x 60mm Reform Ti HA Coated Pedicle Screw
• 00815362029312: 8.5 x 55mm Reform Ti HA Coated Pedicle Screw
• 00815362029305: 8.5 x 50mm Reform Ti HA Coated Pedicle Screw
• 00815362029299: 8.5 x 45mm Reform Ti HA Coated Pedicle Screw
• 00815362029282: 8.5 x 40mm Reform Ti HA Coated Pedicle Screw
• 00815362029275: 8.5 x 35mm Reform Ti HA Coated Pedicle Screw
• 00815362029268: 7.5 x 80mm Reform Ti HA Coated Pedicle Screw
• 00815362029251: 7.5 x 75mm Reform Ti HA Coated Pedicle Screw
• 00815362029244: 7.5 x 60mm Reform Ti HA Coated Pedicle Screw
• 00815362029237: 7.5 x 55mm Reform Ti HA Coated Pedicle Screw
• 00815362029220: 7.5 x 50mm Reform Ti HA Coated Pedicle Screw
• 00815362029213: 7.5 x 45mm Reform Ti HA Coated Pedicle Screw
• 00815362029206: 7.5 x 40mm Reform Ti HA Coated Pedicle Screw
• 00815362029190: 7.5 x 35mm Reform Ti HA Coated Pedicle Screw
• 00815362029183: 7.5 x 30mm Reform Ti HA Coated Pedicle Screw
• 00815362029176: 6.5 x 60mm Reform Ti HA Coated Pedicle Screw
• 00815362029169: 6.5 x 55mm Reform Ti HA Coated Pedicle Screw
• 00815362029152: 6.5 x 50mm Reform Ti HA Coated Pedicle Screw
• 00815362029145: 6.5 x 45mm Reform Ti HA Coated Pedicle Screw
• 00815362029138: 6.5 x 40mm Reform Ti HA Coated Pedicle Screw
• 00815362029121: 6.5 x 35mm Reform Ti HA Coated Pedicle Screw
• 00815362029114: 6.5 x 30mm Reform Ti HA Coated Pedicle Screw