85mm, 2.7mm Cortical Screw, Self-Tapping 327-1085

GUDID 00816950025389

85mm, 2.7mm Cortical Screw, Self-Tapping

Osteocentric Technologies, Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00816950025389
• NIH Device Record Key: 27371ca3-67a0-4c26-8515-7e25faeeff5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 85mm, 2.7mm Cortical Screw, Self-Tapping
• Version Model Number: 327-1085
• Catalog Number: 327-1085
• 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
• 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
• 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: 2.7 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 85 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816950025389 [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

[00816950025389]

Moist Heat or Steam Sterilization

[00816950025389]

Moist Heat or Steam Sterilization

[00816950025389]

Moist Heat or Steam Sterilization

[00816950025389]

Moist Heat or Steam Sterilization

[00816950025389]

Moist Heat or Steam Sterilization

[00816950025389]

Moist Heat or Steam Sterilization

[00816950025389]

Moist Heat or Steam Sterilization

[00816950025389]

Moist Heat or Steam Sterilization

[00816950025389]

Moist Heat or Steam Sterilization

[00816950025389]

Moist Heat or Steam Sterilization

[00816950025389]

Moist Heat or Steam Sterilization

[00816950025389]

Moist Heat or Steam Sterilization

[00816950025389]

Moist Heat or Steam Sterilization

[00816950025389]

Moist Heat or Steam Sterilization

[00816950025389]

Moist Heat or Steam Sterilization

[00816950025389]

Moist Heat or Steam Sterilization

[00816950025389]

Moist Heat or Steam Sterilization

[00816950025389]

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

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