POST-LAT DISTAL FIBULA PLATE 12H R 319-12012

GUDID 00810074309325

POST-LAT DISTAL FIBULA PLATE 12H R

Osteocentric Technologies, Inc.

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 00810074309325
• NIH Device Record Key: 770d41eb-a40e-462a-bbb8-1de48bd4615f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POST-LAT DISTAL FIBULA PLATE 12H R
• Version Model Number: 319-12012
• Catalog Number: 319-12012
• 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: 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
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810074309325 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190430

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[00810074309325]

Moist Heat or Steam Sterilization

[00810074309325]

Moist Heat or Steam Sterilization

[00810074309325]

Moist Heat or Steam Sterilization

[00810074309325]

Moist Heat or Steam Sterilization

[00810074309325]

Moist Heat or Steam Sterilization

[00810074309325]

Moist Heat or Steam Sterilization

[00810074309325]

Moist Heat or Steam Sterilization

[00810074309325]

Moist Heat or Steam Sterilization

[00810074309325]

Moist Heat or Steam Sterilization

[00810074309325]

Moist Heat or Steam Sterilization

[00810074309325]

Moist Heat or Steam Sterilization

[00810074309325]

Moist Heat or Steam Sterilization

[00810074309325]

Moist Heat or Steam Sterilization

[00810074309325]

Moist Heat or Steam Sterilization

[00810074309325]

Moist Heat or Steam Sterilization

[00810074309325]

Moist Heat or Steam Sterilization

[00810074309325]

Moist Heat or Steam Sterilization

[00810074309325]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-19
• Device Publish Date: 2025-05-09

Devices Manufactured by Osteocentric Technologies, Inc.

• 00810074300353 - 9mm Washer 0.9mm Height: 2025-05-26 9mm Washer 0.9mm Height
• 00810074306461 - 8.0mm Drill Bit Cann Hudson Mod 270mm: 2025-05-23 8.0mm Drill Bit Cann Hudson Mod 270mm
• 00810074306997 - 2.7mm Cortical Screw Tap 145mm: 2025-05-23 2.7mm Cortical Screw Tap 145mm
• 00810074307000 - 2.0mm Drill Calibrated 145mm: 2025-05-23 2.0mm Drill Calibrated 145mm
• 00816950029530 - Large Depth Gauge 125mm: 2025-05-23 Large Depth Gauge 125mm
• 00810074309219 - POST-LAT DISTAL FIBULA PLATE 2H L: 2025-05-19 POST-LAT DISTAL FIBULA PLATE 2H L
• 00810074309226 - POST-LAT DISTAL FIBULA PLATE 2H R: 2025-05-19 POST-LAT DISTAL FIBULA PLATE 2H R
• 00810074309233 - POST-LAT DISTAL FIBULA PLATE 4H L: 2025-05-19 POST-LAT DISTAL FIBULA PLATE 4H L