4.0 X 48mm CANN SCREW FASTENER FULL THD 320-40048-03

GUDID 00810074304795

4.0 X 48mm CANN SCREW FASTENER FULL THD

Osteocentric Technologies, Inc.

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 00810074304795
• NIH Device Record Key: 4e46ece7-b5c7-4543-9dd3-1dc1dbd54960
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4.0 X 48mm CANN SCREW FASTENER FULL THD
• Version Model Number: 320-40048-03
• Catalog Number: 320-40048-03
• Company DUNS: 089645059
• Company Name: Osteocentric Technologies, 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com

Device Dimensions

• Outer Diameter: 4 Millimeter
• Length: 48 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 48 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 48 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 48 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 48 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 48 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 48 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 48 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 48 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810074304795 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170021

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00810074304795]

Moist Heat or Steam Sterilization

[00810074304795]

Moist Heat or Steam Sterilization

[00810074304795]

Moist Heat or Steam Sterilization

[00810074304795]

Moist Heat or Steam Sterilization

[00810074304795]

Moist Heat or Steam Sterilization

[00810074304795]

Moist Heat or Steam Sterilization

[00810074304795]

Moist Heat or Steam Sterilization

[00810074304795]

Moist Heat or Steam Sterilization

[00810074304795]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-12
• Device Publish Date: 2024-12-04

Devices Manufactured by Osteocentric Technologies, Inc.

• 00810074306430 - Nut Driver: 2025-01-15 Nut Driver
• 00810074306454 - 2.7MM GUIDE WIRE DRILL TIP SS 600MM: 2025-01-15 2.7MM GUIDE WIRE DRILL TIP SS 600MM
• 00810097802872 - 8.0MM TAP CANN HUD-MOD: 2025-01-15 8.0MM TAP CANN HUD-MOD
• 00810097803473 - PRIMARY DEPTH GAUGE: 2025-01-15 PRIMARY DEPTH GAUGE
• 00810074302364 - 120mm Locking Lateral Distal Fibula Plate Left: 2024-12-17 120mm Locking Lateral Distal Fibula Plate Left
• 00810074302371 - 140mm Locking Lateral Distal Fibula Plate Left: 2024-12-17 140mm Locking Lateral Distal Fibula Plate Left
• 00810074302388 - 120mm Locking Lateral Distal Fibula Plate Right: 2024-12-17 120mm Locking Lateral Distal Fibula Plate Right
• 00810074302395 - 140mm Locking Lateral Distal Fibula Plate Right: 2024-12-17 140mm Locking Lateral Distal Fibula Plate Right