Libertas

GUDID 00810008121870

Bone Screw Ø6.5 x 45mm

MAXX ORTHOPEDICS, INC.

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00810008121870
• NIH Device Record Key: d2fc3d5e-27f5-4969-bcd1-99b8dc5eff52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Libertas
• Version Model Number: MO-SWCC-65/45
• Company DUNS: 792030103
• Company Name: MAXX ORTHOPEDICS, 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: true
• 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	00810008121870 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180973

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented

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: 2024-02-19
• Device Publish Date: 2022-12-08

On-Brand Devices [Libertas]

• 00810008121887: Bone Screw Ø6.5 x 50mm
• 00810008121870: Bone Screw Ø6.5 x 45mm
• 00810008121863: Bone Screw Ø6.5 x 40mm
• 00810008121856: Bone Screw Ø6.5 x 35mm
• 00810008121849: Bone Screw Ø6.5 x 30mm
• 00810008121832: Bone Screw Ø6.5 x 25mm
• 00810008121825: Bone Screw Ø6.5 x 20mm
• 00810008121818: Bone Screw Ø6.5 x 15mm