Ø8.0 x 90mm x 24mm CANNULATED PARTIAL THREAD 380-5090-024

GUDID 00816950027253

Ø8.0 x 90mm x 24mm CANNULATED PARTIAL THREAD

Osteocentric Technologies, Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00816950027253
• NIH Device Record Key: 230f9b91-9222-4125-a437-897d44abcfcb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ø8.0 x 90mm x 24mm CANNULATED PARTIAL THREAD
• Version Model Number: 380-5090-024
• Catalog Number: 380-5090-024
• 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
• Phone: 1800-969-0639
• Email: quality@osteocentric.com
• Phone: 1800-969-0639
• Email: quality@osteocentric.com
• Phone: 1800-969-0639
• Email: quality@osteocentric.com
• Phone: 1800-969-0639
• Email: quality@osteocentric.com
• Phone: 1800-969-0639
• Email: quality@osteocentric.com
• Phone: 1800-969-0639
• Email: quality@osteocentric.com
• Phone: 1800-969-0639
• Email: quality@osteocentric.com
• Phone: 1800-969-0639
• Email: quality@osteocentric.com
• Phone: 1800-969-0639
• Email: quality@osteocentric.com
• Phone: 1800-969-0639
• Email: quality@osteocentric.com
• Phone: 1800-969-0639
• Email: quality@osteocentric.com
• Phone: 1800-969-0639
• Email: quality@osteocentric.com
• Phone: 1800-969-0639
• Email: quality@osteocentric.com
• Phone: 1800-969-0639
• Email: quality@osteocentric.com
• Phone: 1800-969-0639
• Email: quality@osteocentric.com
• Phone: 1800-969-0639
• Email: quality@osteocentric.com
• Phone: 1800-969-0639
• Email: quality@osteocentric.com

Device Dimensions

• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816950027253 [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

[00816950027253]

Moist Heat or Steam Sterilization

[00816950027253]

Moist Heat or Steam Sterilization

[00816950027253]

Moist Heat or Steam Sterilization

[00816950027253]

Moist Heat or Steam Sterilization

[00816950027253]

Moist Heat or Steam Sterilization

[00816950027253]

Moist Heat or Steam Sterilization

[00816950027253]

Moist Heat or Steam Sterilization

[00816950027253]

Moist Heat or Steam Sterilization

[00816950027253]

Moist Heat or Steam Sterilization

[00816950027253]

Moist Heat or Steam Sterilization

[00816950027253]

Moist Heat or Steam Sterilization

[00816950027253]

Moist Heat or Steam Sterilization

[00816950027253]

Moist Heat or Steam Sterilization

[00816950027253]

Moist Heat or Steam Sterilization

[00816950027253]

Moist Heat or Steam Sterilization

[00816950027253]

Moist Heat or Steam Sterilization

[00816950027253]

Moist Heat or Steam Sterilization

[00816950027253]

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.

• 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