Tritium™* Sternal Cable Plate System 86-30-18-S4

GUDID 00846468061784

Screw, Ø3.0mm X 18mm, 4 Pack

Pioneer Surgical Technology, Inc.

Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device

• Primary Device ID: 00846468061784
• NIH Device Record Key: 0a6752b7-0dde-4e69-aa85-fbc877f4df22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tritium™* Sternal Cable Plate System
• Version Model Number: 86-30-18-S4
• Catalog Number: 86-30-18-S4
• Company DUNS: 793384496
• Company Name: Pioneer Surgical Technology, Inc.
• Device Count: 1
• DM Exempt: false
• 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: 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	00846468061784 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150581

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-11-06

On-Brand Devices [Tritium™* Sternal Cable Plate System]

• 00846468066710: SCP Dbl Cable Plate, 64mm Needle
• 00846468063764: SCP Rib Plate
• 00846468061814: Screw, Ø3.0mm X 20mm, 4 Pack
• 00846468061807: Screw, Ø3.0mm X 20mm, 2 Pack
• 00846468061784: Screw, Ø3.0mm X 18mm, 4 Pack
• 00846468061777: Screw, Ø3.0mm X 18mm, 2 Pack
• 00846468061753: Screw, Ø3.0mm X 16mm, 4 Pack
• 00846468061746: Screw, Ø3.0mm X 16mm, 2 Pack
• 00846468061722: Screw, Ø3.0mm X 14mm, 4 Pack
• 00846468061715: Screw, Ø3.0mm X 14mm, 2 Pack
• 00846468061692: Screw, Ø3.0mm X 12mm, 4 Pack
• 00846468061685: Screw, Ø3.0mm X 12mm, 2 Pack
• 00846468061678: Screw, Ø3.0mm X 12mm, 12 Pack
• 00846468061661: Screw, Ø3.0mm X 10mm, 4 Pack
• 00846468061654: Screw, Ø3.0mm X 10mm, 2 Pack
• 00846468061630: Screw, Ø3.0mm X 8mm, 4 Pack
• 00846468061623: Screw, Ø3.0mm X 8mm, 2 Pack
• 00846468061609: Screw, Ø2.7mm X 20mm, 4 Pack
• 00846468061593: Screw, Ø2.7mm X 20mm, 2 Pack
• 00846468061579: Screw, Ø2.7mm X 18mm, 4 Pack
• 00846468049775: SCP, Aux Plate Assy
• 00846468049768: SCP, Box-Plate Assembly
• 00846468049751: SCP, Dbl Cbl Plate Assy