Sure-Lok Extended Tab Pedicle Screw System 48-3000-8580

GUDID 00840019909259

Percutaneous Screw 8.5 X 80mm

PRECISION SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840019909259
• NIH Device Record Key: fba964f3-9f4f-4327-b997-128b90441b35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sure-Lok Extended Tab Pedicle Screw System
• Version Model Number: 48-3000-8580
• Catalog Number: 48-3000-8580
• 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	00840019909259 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141397

FDA Product Code

• MNH: Orthosis, Spondylolisthesis Spinal Fixation

Sterilization

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

[00840019909259]

Moist Heat or Steam Sterilization

[00840019909259]

Moist Heat or Steam Sterilization

[00840019909259]

Moist Heat or Steam Sterilization

[00840019909259]

Moist Heat or Steam Sterilization

[00840019909259]

Moist Heat or Steam Sterilization

[00840019909259]

Moist Heat or Steam Sterilization

[00840019909259]

Moist Heat or Steam Sterilization

[00840019909259]

Moist Heat or Steam Sterilization

[00840019909259]

Moist Heat or Steam Sterilization

[00840019909259]

Moist Heat or Steam Sterilization

[00840019909259]

Moist Heat or Steam Sterilization

[00840019909259]

Moist Heat or Steam Sterilization

[00840019909259]

Moist Heat or Steam Sterilization

[00840019909259]

Moist Heat or Steam Sterilization

[00840019909259]

Moist Heat or Steam Sterilization

[00840019909259]

Moist Heat or Steam Sterilization

[00840019909259]

Moist Heat or Steam Sterilization

[00840019909259]

Moist Heat or Steam Sterilization

[00840019909259]

Moist Heat or Steam Sterilization

[00840019909259]

Moist Heat or Steam Sterilization

[00840019909259]

Moist Heat or Steam Sterilization

[00840019909259]

Moist Heat or Steam Sterilization

[00840019909259]

Moist Heat or Steam Sterilization

[00840019909259]

Moist Heat or Steam Sterilization

[00840019909259]

Moist Heat or Steam Sterilization

[00840019909259]

Moist Heat or Steam Sterilization

[00840019909259]

Moist Heat or Steam Sterilization

[00840019909259]

Moist Heat or Steam Sterilization

[00840019909259]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-23
• Device Publish Date: 2019-04-15

On-Brand Devices [Sure-Lok Extended Tab Pedicle Screw System ]

• 00840019922685: Instrument & Implant Tray (Empty)
• 00840019922678: K-Wire, SS Trocar/Blunt Tip
• 00840019922654: K-Wire, NI Trocar/Blunt Tip
• 00840019922647: K-Wire, NI Trocar/Threaded
• 00840019922630: K-Wire 1.6mm Diameter, Rounded
• 00840019922623: "Perc" Kwire (.062 X 21.0)
• 00840019922616: "Perc" Kwire (.062 X 21.0)
• 00840019922609: cap screw inserter
• 00840019922593: Percutaneous screwdriver
• 00840019922579: Caliper
• 00840019922555: Rod Inserter - bayonneted
• 00840019922548: Bottle Cap Straight
• 00840019922531: Sleeve, Straight
• 00840019922517: Sleeve, All in One
• 00840019922692: Implant Tray (Empty)
• 00840019922661: K-Wire, SS Trocar/Threaded
• 00840019922586: Tab Remover
• 00840019922562: Anti Torque (closed)
• 00840019922524: Bottle Cap Reduction
• 00840019909228: Percutaneous Screw 8.5 X 55mm
• 00840019908924: Percutaneous Screw 5.5 X 30mm
• 00840019908917: Percutaneous Screw 5.5 X 25mm
• 00840019909600: 150mm straight rod
• 00840019909594: 140mm straight rod
• 00840019909587: 130mm straight rod
• 00840019909570: 120mm straight rod
• 00840019909563: 110mm straight rod
• 00840019909556: 100mm straight rod
• 00840019909549: 90mm Straight Rod
• 00840019909532: 80mm Straight Rod
• 00840019909525: 75mm Straight Rod
• 00840019909518: 70mm Straight Rod
• 00840019909501: 65mm Straight Rod
• 00840019909495: 60mm Straight Rod
• 00840019909488: 55mm Straight Rod
• 00840019909471: 50mm Straight Rod
• 00840019909464: 45mm Straight Rod
• 00840019909457: 40mm Straight Rod
• 00840019909440: 35mm Straight Rod
• 00840019909433: 150mm curved rod
• 00840019909426: 140mm curved rod
• 00840019909419: 130mm curved rod
• 00840019909402: 120mm curved rod
• 00840019909396: 110mm curved rod
• 00840019909389: 100mm curved rod
• 00840019909372: 90mm curved rod
• 00840019909365: 80mm curved rod
• 00840019909358: 75mm curved rod
• 00840019909341: 70mm curved rod
• 00840019909334: 65mm curved rod