REMEDY Poly+Plus Tibial Spacer RTPTLG13

GUDID 00850011453438

REMEDY® POLY+PLUS Tibial Trial LG 13 mm

OSTEOREMEDIES, LLC

Knee tibia prosthesis trial, reusable

• Primary Device ID: 00850011453438
• NIH Device Record Key: c366ad0b-793b-4c9b-abdc-7f3a7fddcf45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REMEDY Poly+Plus Tibial Spacer
• Version Model Number: RTPTLG13
• Catalog Number: RTPTLG13
• Company DUNS: 079596704
• Company Name: OSTEOREMEDIES, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850011453438 [Primary]

FDA Product Code

• HWT: Template

Sterilization

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

[00850011453438]

Moist Heat or Steam Sterilization

[00850011453438]

Moist Heat or Steam Sterilization

[00850011453438]

Moist Heat or Steam Sterilization

[00850011453438]

Moist Heat or Steam Sterilization

[00850011453438]

Moist Heat or Steam Sterilization

[00850011453438]

Moist Heat or Steam Sterilization

[00850011453438]

Moist Heat or Steam Sterilization

[00850011453438]

Moist Heat or Steam Sterilization

[00850011453438]

Moist Heat or Steam Sterilization

[00850011453438]

Moist Heat or Steam Sterilization

[00850011453438]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-24
• Device Publish Date: 2025-12-16

On-Brand Devices [REMEDY Poly+Plus Tibial Spacer ]

• 00850011453452: Remedy POLY+PLUS Tibia Case Base
• 00850011453445: REMEDY® POLY+PLUS Tibial Trial LG 17 mm
• 00850011453438: REMEDY® POLY+PLUS Tibial Trial LG 13 mm
• 00850011453421: REMEDY® POLY+PLUS Tibial Trial MD 17 mm
• 00850011453414: REMEDY® POLY+PLUS Tibial Trial MD 13 mm
• 00850011453407: REMEDY® POLY+PLUS Tibial Trial SM 17 mm
• 00850011453391: REMEDY® POLY+PLUS Tibial Trial SM 13 mm
• 00850011453384: REMEDY® POLY+PLUS Tibial Comp. LG 17mm
• 00850011453377: REMEDY® POLY+PLUS Tibial Comp. LG 13mm
• 00850011453360: REMEDY® POLY+PLUS Tibial Comp. MD 17mm
• 00850011453353: REMEDY® POLY+PLUS Tibial Comp. MD 13mm
• 00850011453346: REMEDY® POLY+PLUS Tibial Comp. SM 17mm
• 00850011453339: REMEDY® POLY+PLUS Tibial Comp. SM 13mm