Reform MC HA Coated Pedicle Screw System 59-HBP-1060

GUDID 00840019959346

Ø10.5 x 60mm Midline Cortical Bone Screw

PRECISION SPINE, INC.

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 00840019959346
• NIH Device Record Key: 20bc6db9-b999-4668-bb1f-6fc97f76512e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reform MC HA Coated Pedicle Screw System
• Version Model Number: 59-HBP-1060
• Catalog Number: 59-HBP-1060
• 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	00840019959346 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173130

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: 2022-08-09
• Device Publish Date: 2022-08-01

On-Brand Devices [Reform MC HA Coated Pedicle Screw System]

• 00840019958189: Ø5.5 x 25mm Midline Cortical Bone Screw, Cannulated
• 00840019958172: Ø4.5 x 45mm Midline Cortical Bone Screw, Cannulated
• 00840019958165: Ø4.5 x 40mm Midline Cortical Bone Screw, Cannulated
• 00840019958158: Ø4.5 x 35mm Midline Cortical Bone Screw, Cannulated
• 00840019958134: Ø4.5 x 25mm Midline Cortical Bone Screw, Cannulated
• 00840019958837: Ø5.5 x 30mm Midline Cortical Bone Screw
• 00840019958820: Ø5.5 x 25mm Midline Cortical Bone Screw
• 00840019958813: Ø4.5 x 45mm Midline Cortical Bone Screw
• 00840019958806: Ø4.5 x 40mm Midline Cortical Bone Screw
• 00840019958790: Ø4.5 x 35mm Midline Cortical Bone Screw
• 00840019958783: Ø4.5 x 30mm Midline Cortical Bone Screw
• 00840019958776: Ø4.5 x 25mm Midline Cortical Bone Screw
• 00840019958769: Ø10.5 x 120mm Midline Cortical Bone Screw, Cannulated
• 00840019958752: Ø10.5 x 110mm Midline Cortical Bone Screw, Cannulated
• 00840019958745: Ø10.5 x 100mm Midline Cortical Bone Screw, Cannulated
• 00840019958738: Ø10.5 x 90mm Midline Cortical Bone Screw, Cannulated
• 00840019958721: Ø10.5 x 80mm Midline Cortical Bone Screw, Cannulated
• 00840019958714: Ø10.5 x 70mm Midline Cortical Bone Screw, Cannulated
• 00840019958707: Ø10.5 x 60mm Midline Cortical Bone Screw, Cannulated
• 00840019958691: Ø10.5 x 55mm Midline Cortical Bone Screw, Cannulated
• 00840019958684: Ø10.5 x 50mm Midline Cortical Bone Screw, Cannulated
• 00840019958677: Ø10.5 x 45mm Midline Cortical Bone Screw, Cannulated
• 00840019958660: Ø10.5 x 40mm Midline Cortical Bone Screw, Cannulated
• 00840019958653: Ø9.5 x 120mm Midline Cortical Bone Screw, Cannulated
• 00840019958646: Ø9.5 x 110mm Midline Cortical Bone Screw, Cannulated
• 00840019958639: Ø9.5 x 100mm Midline Cortical Bone Screw, Cannulated
• 00840019958622: Ø9.5 x 90mm Midline Cortical Bone Screw, Cannulated
• 00840019958615: Ø9.5 x 80mm Midline Cortical Bone Screw, Cannulated
• 00840019958608: Ø9.5 x 70mm Midline Cortical Bone Screw, Cannulated
• 00840019958592: Ø9.5 x 60mm Midline Cortical Bone Screw, Cannulated
• 00840019958585: Ø9.5 x 55mm Midline Cortical Bone Screw, Cannulated
• 00840019958578: Ø9.5 x 50mm Midline Cortical Bone Screw, Cannulated
• 00840019958561: Ø9.5 x 45mm Midline Cortical Bone Screw, Cannulated
• 00840019958554: Ø9.5 x 40mm Midline Cortical Bone Screw, Cannulated
• 00840019958547: Ø8.5 x 120mm Midline Cortical Bone Screw, Cannulated
• 00840019958530: Ø8.5 x 110mm Midline Cortical Bone Screw, Cannulated
• 00840019958523: Ø8.5 x 100mm Midline Cortical Bone Screw, Cannulated
• 00840019958516: Ø8.5 x 90mm Midline Cortical Bone Screw, Cannulated
• 00840019958509: Ø8.5 x 80mm Midline Cortical Bone Screw, Cannulated
• 00840019958493: Ø8.5 x 70mm Midline Cortical Bone Screw, Cannulated
• 00840019958486: Ø8.5 x60mm Midline Cortical Bone Screw, Cannulated
• 00840019958479: Ø8.5 x 55mm Midline Cortical Bone Screw, Cannulated
• 00840019958462: Ø8.5 x 50mm Midline Cortical Bone Screw, Cannulated
• 00840019958455: Ø8.5 x 45mm Midline Cortical Bone Screw, Cannulated
• 00840019958448: Ø8.5 x 40mm Midline Cortical Bone Screw, Cannulated
• 00840019958431: Ø8.5 x 35mm Midline Cortical Bone Screw, Cannulated
• 00840019958424: Ø7.5 x 80mm Midline Cortical Bone Screw, Cannulated
• 00840019958417: Ø7.5 x 70mm Midline Cortical Bone Screw, Cannulated
• 00840019958400: Ø7.5 x 60mm Midline Cortical Bone Screw, Cannulated
• 00840019958394: Ø7.5 x 55mm Midline Cortical Bone Screw, Cannulated