48mm, 2.7mm Cortical Screw, Self-Tapping 327-1048

GUDID 00816950020919

48mm, 2.7mm Cortical Screw, Self-Tapping

Osteocentric Technologies, Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00816950020919
• NIH Device Record Key: 5caeb471-262b-421c-8f72-1ef607264b95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 48mm, 2.7mm Cortical Screw, Self-Tapping
• Version Model Number: 327-1048
• Catalog Number: 327-1048
• 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: 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

Customer Support Contacts

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

Device Dimensions

• Outer Diameter: 2.7 Millimeter
• Length: 48 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816950020919 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150981

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00816950020919]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2024-02-19
• Device Publish Date: 2020-06-17

Devices Manufactured by Osteocentric Technologies, Inc.

• 00816950020773 - 34mm, 2.7mm Cortical Screw, Self-Tapping: 2024-02-19 34mm, 2.7mm Cortical Screw, Self-Tapping
• 00816950020797 - 36mm, 2.7mm Cortical Screw, Self-Tapping: 2024-02-19 36mm, 2.7mm Cortical Screw, Self-Tapping
• 00816950020810 - 38mm, 2.7mm Cortical Screw, Self-Tapping: 2024-02-19 38mm, 2.7mm Cortical Screw, Self-Tapping
• 00816950020834 - 40mm, 2.7mm Cortical Screw, Self-Tapping: 2024-02-19 40mm, 2.7mm Cortical Screw, Self-Tapping
• 00816950020858 - 42mm, 2.7mm Cortical Screw, Self-Tapping: 2024-02-19 42mm, 2.7mm Cortical Screw, Self-Tapping
• 00816950020872 - 44mm, 2.7mm Cortical Screw, Self-Tapping: 2024-02-19 44mm, 2.7mm Cortical Screw, Self-Tapping
• 00816950020896 - 46mm, 2.7mm Cortical Screw, Self-Tapping: 2024-02-19 46mm, 2.7mm Cortical Screw, Self-Tapping
• 00816950020919 - 48mm, 2.7mm Cortical Screw, Self-Tapping: 2024-02-1948mm, 2.7mm Cortical Screw, Self-Tapping
• 00816950020919 - 48mm, 2.7mm Cortical Screw, Self-Tapping: 2024-02-19 48mm, 2.7mm Cortical Screw, Self-Tapping