RCS Anterior Buttress Plate System 22-1001-25

GUDID 00815362020975

RCS Buttress Plate 25mm

PRECISION SPINE, INC.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00815362020975
• NIH Device Record Key: 3b36a3d4-67db-47ea-844e-202ad064d971
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RCS Anterior Buttress Plate System
• Version Model Number: 22-1001-25
• Catalog Number: 22-1001-25
• 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: false
• 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	00815362020975 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092659

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00815362020975]

Moist Heat or Steam Sterilization

[00815362020975]

Moist Heat or Steam Sterilization

[00815362020975]

Moist Heat or Steam Sterilization

[00815362020975]

Moist Heat or Steam Sterilization

[00815362020975]

Moist Heat or Steam Sterilization

[00815362020975]

Moist Heat or Steam Sterilization

[00815362020975]

Moist Heat or Steam Sterilization

[00815362020975]

Moist Heat or Steam Sterilization

[00815362020975]

Moist Heat or Steam Sterilization

[00815362020975]

Moist Heat or Steam Sterilization

[00815362020975]

Moist Heat or Steam Sterilization

[00815362020975]

Moist Heat or Steam Sterilization

[00815362020975]

Moist Heat or Steam Sterilization

[00815362020975]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-08
• Device Publish Date: 2019-03-29

On-Brand Devices [RCS Anterior Buttress Plate System]

• 00815362021071: Buttress Plate Case
• 00815362021057: RCS Buttress Screwdriver Straight 3.5mm
• 00815362021040: 22-9002
• 00815362021033: RCS Buttress Inserter Tool
• 00815362021026: Self Drilling Screw 5.5mm x 35mm
• 00815362021019: Self Drilling Screw 5.5mm x 30mm
• 00815362021002: Self Drilling Screw 5.5mm x 25mm
• 00815362020999: Self Drilling Screw 5.5mm x 20mm
• 00815362020982: RCS Buttress Plate 30mm
• 00815362020975: RCS Buttress Plate 25mm
• 00840019936224: Buttress Plate Tray 1 Assembly