2.8 mm Headless Compression Screw Fastener EX01-5028-12

GUDID 00850015496011

2.8 mm Headless Compression Screw Fastener 12mm Long

Osteocentric Technologies, Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00850015496011
• NIH Device Record Key: 08dc6fc4-748a-4916-bf85-0c262d733ba0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2.8 mm Headless Compression Screw Fastener
• Version Model Number: EX01-5028-12
• Catalog Number: EX01-5028-12
• 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: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com
• Phone: 1 800 969 0639
• Email: info@osteocentric.com

Device Dimensions

• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 2.8 Millimeter
• Length: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850015496011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200259

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

[00850015496011]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-08-16
• Device Publish Date: 2020-06-10

On-Brand Devices [2.8 mm Headless Compression Screw Fastener]

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• 00850015496097: 2.8 mm Headless Compression Screw Fastener 28mm Long
• 00850015496080: 2.8 mm Headless Compression Screw Fastener 26mm Long
• 00850015496073: 2.8 mm Headless Compression Screw Fastener 24mm Long
• 00850015496066: 2.8 mm Headless Compression Screw Fastener 22mm Long
• 00850015496059: 2.8 mm Headless Compression Screw Fastener 20mm Long
• 00850015496042: 2.8 mm Headless Compression Screw Fastener 18mm Long
• 00850015496035: 2.8 mm Headless Compression Screw Fastener 16mm Long
• 00850015496028: 2.8 mm Headless Compression Screw Fastener 14mm Long
• 00850015496011: 2.8 mm Headless Compression Screw Fastener 12mm Long