Rogue 114-230

GUDID 00190837069896

Life Spine, Inc.

Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable

• Primary Device ID: 00190837069896
• NIH Device Record Key: 966869ee-053c-4a1e-b48f-7046749823e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rogue
• Version Model Number: 114-230
• Catalog Number: 114-230
• Company DUNS: 183641617
• Company Name: Life Spine, 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: false
• Lot Batch: true
• 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	00190837069896 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171448

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[00190837069896]

Moist Heat or Steam Sterilization

[00190837069896]

Moist Heat or Steam Sterilization

[00190837069896]

Moist Heat or Steam Sterilization

[00190837069896]

Moist Heat or Steam Sterilization

[00190837069896]

Moist Heat or Steam Sterilization

[00190837069896]

Moist Heat or Steam Sterilization

[00190837069896]

Moist Heat or Steam Sterilization

[00190837069896]

Moist Heat or Steam Sterilization

[00190837069896]

Moist Heat or Steam Sterilization

[00190837069896]

Moist Heat or Steam Sterilization

[00190837069896]

Moist Heat or Steam Sterilization

[00190837069896]

Moist Heat or Steam Sterilization

[00190837069896]

Moist Heat or Steam Sterilization

[00190837069896]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-15
• Device Publish Date: 2019-11-07

On-Brand Devices [Rogue]

• 00190837070106: Rogue Template
• 00190837070090: Hammertoe Counter Push
• 00190837070083: Hammertoe Handle Turn Knob
• 00190837070076: Hammertoe Handle Body
• 00190837070069: Hammertoe Handle Turn Knob
• 00190837070052: Hammertoe Handle Body
• 00190837070045: Hammertoe Handle Turn Knob
• 00190837070038: Hammertoe Handle Turn Knob
• 00190837070021: Hammertoe Handle Knob
• 00190837070014: Hammertoe Turn Knob
• 00190837070007: Hammertoe Drive Handle
• 00190837069995: Counter Push Caddy
• 00190837069988: Small Driver Caddy
• 00190837069971: Large Driver Caddy
• 00190837069964: Step Drill Caddy
• 00190837069957: Implant Caddy
• 00190837069940: Hammertoe Caddy
• 00190837069933: Hammertoe Counter Push
• 00190837069926: Small Hammertoe Driver, 2.0mm Diameter
• 00190837069919: Large Hammertoe Driver, 2.9mm Diameter
• 00190837069902: Hammertoe Step Drill
• 00190837069896: 114-230
• 00190837069889: 114-206
• 00190837069872: Compression Screw Tray