Ø7.0 x 170mm CANNULATED FULL THREAD SCREW 370-5170-001

GUDID 00816950026645

Ø7.0 x 170mm CANNULATED FULL THREAD SCREW

Osteocentric Technologies, Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00816950026645
• NIH Device Record Key: 18e1671c-801e-49e0-8460-db2d03a9872d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ø7.0 x 170mm CANNULATED FULL THREAD SCREW
• Version Model Number: 370-5170-001
• Catalog Number: 370-5170-001
• 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: 1800-969-0639
• Email: info@osteocentric.com

Device Dimensions

• Length: 170 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816950026645 [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

[00816950026645]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-02-19
• Device Publish Date: 2020-04-21

Devices Manufactured by Osteocentric Technologies, Inc.

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• 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: 2024-02-19 48mm, 2.7mm Cortical Screw, Self-Tapping