REMEDY Poly+Plus Tibial Spacer RPPSM13

GUDID 00850011453339

REMEDY® POLY+PLUS Tibial Comp. SM 13mm

OSTEOREMEDIES, LLC

Uncoated unicondylar knee tibia prosthesis, polyethylene

• Primary Device ID: 00850011453339
• NIH Device Record Key: 0b96816a-1bb9-4e54-8763-209666a128c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REMEDY Poly+Plus Tibial Spacer
• Version Model Number: RPPSM13
• Catalog Number: RPPSM13
• Company DUNS: 079596704
• Company Name: OSTEOREMEDIES, LLC
• 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: true
• 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	00850011453339 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242377

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

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

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