POST-LAT DISTAL FIBULA PLATE 8H R 319-12008

GUDID 00810074309288

POST-LAT DISTAL FIBULA PLATE 8H R

Osteocentric Technologies, Inc.

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 00810074309288
• NIH Device Record Key: a214705e-a208-46fd-9c81-f66489638844
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POST-LAT DISTAL FIBULA PLATE 8H R
• Version Model Number: 319-12008
• Catalog Number: 319-12008
• 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	00810074309288 [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

[00810074309288]

Moist Heat or Steam Sterilization

[00810074309288]

Moist Heat or Steam Sterilization

[00810074309288]

Moist Heat or Steam Sterilization

[00810074309288]

Moist Heat or Steam Sterilization

[00810074309288]

Moist Heat or Steam Sterilization

[00810074309288]

Moist Heat or Steam Sterilization

[00810074309288]

Moist Heat or Steam Sterilization

[00810074309288]

Moist Heat or Steam Sterilization

[00810074309288]

Moist Heat or Steam Sterilization

[00810074309288]

Moist Heat or Steam Sterilization

[00810074309288]

Moist Heat or Steam Sterilization

[00810074309288]

Moist Heat or Steam Sterilization

[00810074309288]

Moist Heat or Steam Sterilization

[00810074309288]

Moist Heat or Steam Sterilization

[00810074309288]

Moist Heat or Steam Sterilization

[00810074309288]

Moist Heat or Steam Sterilization

[00810074309288]

Moist Heat or Steam Sterilization

[00810074309288]

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.

• 00810074307536 - 6.0 x 55mm Bone Screw Fastener ST: 2025-10-06 6.0 x 55mm Bone Screw Fastener ST
• 00810074307543 - 6.0 x 60mm Bone Screw Fastener ST: 2025-10-06 6.0 x 60mm Bone Screw Fastener ST
• 00810074307550 - 6.0 x 65mm Bone Screw Fastener ST: 2025-10-06 6.0 x 65mm Bone Screw Fastener ST
• 00810074308984 - 11 X 75mm LAG FASTENER: 2025-09-30 11 X 75mm LAG FASTENER
• 00810074309974 - 11 X 80mm LAG FASTENER: 2025-09-30 11 X 80mm LAG FASTENER
• 00810074309981 - 11 X 85mm LAG FASTENER: 2025-09-30 11 X 85mm LAG FASTENER
• 00810074309998 - 11 X 90mm LAG FASTENER: 2025-09-30 11 X 90mm LAG FASTENER
• 00810189110007 - 11 X 95mm LAG FASTENER: 2025-09-30 11 X 95mm LAG FASTENER