DRPx Locking Distal Radius Plate System

GUDID 10811998035748

DISTAL RADIUS PLATE, STANDARD, 7H LEFT

ORTHOPAEDIC IMPLANT COMPANY, THE

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 10811998035748
• NIH Device Record Key: 5eb6861a-856d-4bdc-a838-923111fd4c83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DRPx Locking Distal Radius Plate System
• Version Model Number: DRPX-S0789L
• Company DUNS: 070061160
• Company Name: ORTHOPAEDIC IMPLANT COMPANY, THE
• 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: true
• 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: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com

Device Dimensions

• Length: 89 Millimeter
• Device Size Text, specify: 0
• Length: 89 Millimeter
• Device Size Text, specify: 0
• Length: 89 Millimeter
• Device Size Text, specify: 0
• Length: 89 Millimeter
• Device Size Text, specify: 0
• Length: 89 Millimeter
• Device Size Text, specify: 0
• Length: 89 Millimeter
• Device Size Text, specify: 0
• Length: 89 Millimeter
• Device Size Text, specify: 0
• Length: 89 Millimeter
• Device Size Text, specify: 0
• Length: 89 Millimeter
• Device Size Text, specify: 0
• Length: 89 Millimeter
• Device Size Text, specify: 0
• Length: 89 Millimeter
• Device Size Text, specify: 0
• Length: 89 Millimeter
• Device Size Text, specify: 0
• Length: 89 Millimeter
• Device Size Text, specify: 0
• Length: 89 Millimeter
• Device Size Text, specify: 0
• Length: 89 Millimeter
• Device Size Text, specify: 0
• Length: 89 Millimeter
• Device Size Text, specify: 0
• Length: 89 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10811998035748 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202971

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[10811998035748]

Moist Heat or Steam Sterilization

[10811998035748]

Moist Heat or Steam Sterilization

[10811998035748]

Moist Heat or Steam Sterilization

[10811998035748]

Moist Heat or Steam Sterilization

[10811998035748]

Moist Heat or Steam Sterilization

[10811998035748]

Moist Heat or Steam Sterilization

[10811998035748]

Moist Heat or Steam Sterilization

[10811998035748]

Moist Heat or Steam Sterilization

[10811998035748]

Moist Heat or Steam Sterilization

[10811998035748]

Moist Heat or Steam Sterilization

[10811998035748]

Moist Heat or Steam Sterilization

[10811998035748]

Moist Heat or Steam Sterilization

[10811998035748]

Moist Heat or Steam Sterilization

[10811998035748]

Moist Heat or Steam Sterilization

[10811998035748]

Moist Heat or Steam Sterilization

[10811998035748]

Moist Heat or Steam Sterilization

[10811998035748]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-14
• Device Publish Date: 2023-09-06

On-Brand Devices [DRPx Locking Distal Radius Plate System]

• 10811998039463: DRPX STERILIZATION CASE
• 10811998039524: DORSAL SPANNING PLATE, 8H X 210MM
• 10811998039517: DORSAL SPANNING PLATE, 8H X 160MM
• 10811998039494: DRPX DORSAL SPANNING PLATE HANDLE
• 10811998039265: 2.6MM X 12MM SELF-TAP CORTEX SCREW
• 10811998039258: 2.6MM X 10MM SELF-TAP CORTEX SCREW
• 10811998039241: 2.6MM X 8MM SELF-TAP CORTEX SCREW
• 10811998039104: 2.6MM X 12MM VARIABLE ANGLE SCREW
• 10811998039098: 2.6MM X 10MM VARIABLE ANGLE SCREW
• 10811998039081: 2.6MM X 08MM VARIABLE ANGLE SCREW
• 10811998039777: KICKSTAND SHAFT
• 10811998039760: KICKSTAND GUIDE
• 10811998035755: DISTAL RADIUS PLATE, STANDARD, 7H RIGHT
• 10811998035748: DISTAL RADIUS PLATE, STANDARD, 7H LEFT
• 10811998039739: 2.8MM X 95MM CALIBRATED DRILL BIT