Reform HA Coated Pedicle Screw 39-PH-4525

GUDID 00815362020005

4.5 x 25mm Reform HA Coated Pedicle Screw System

PRECISION SPINE, INC.

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 00815362020005
• NIH Device Record Key: 80840b68-a5e1-49e7-8b48-1f1f6648a07b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reform HA Coated Pedicle Screw
• Version Model Number: 39-PH-4525
• Catalog Number: 39-PH-4525
• 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: true
• Serial Number: true
• 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	00815362020005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151422

FDA Product Code

• KWP: Appliance, Fixation, Spinal Interlaminal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-08-07
• Device Publish Date: 2019-03-28

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