Gemini SL 318-483/05

GUDID 04026575419999

Tibia Component - fixed bearing, PS, monoblock

WALDEMAR LINK GmbH & Co. KG

Uncoated knee tibia prosthesis, metallic

• Primary Device ID: 04026575419999
• NIH Device Record Key: 1e7e99cb-3be4-416d-b7b4-f38631a47e9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gemini SL
• Version Model Number: 318-483/05
• Catalog Number: 318-483/05
• Company DUNS: 315675488
• Company Name: WALDEMAR LINK GmbH & Co. KG
• Device Count: 1
• DM Exempt: true
• 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: false
• Serial Number: true
• 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	04026575419999 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182872

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-11
• Device Publish Date: 2019-04-17

On-Brand Devices [Gemini SL]

• 04026575419999: Tibia Component - fixed bearing, PS, monoblock
• 04026575419982: Tibia Component - fixed bearing, PS, monoblock
• 04026575419975: Tibia Component - fixed bearing, PS, monoblock
• 04026575419968: Tibia Component - fixed bearing, PS, monoblock
• 04026575419951: Tibia Component - fixed bearing, PS, monoblock
• 04026575419944: Tibia Component - fixed bearing, PS, monoblock
• 04026575419937: Tibia Component - fixed bearing, PS, monoblock
• 04026575419920: Tibia Component - fixed bearing, PS, monoblock
• 04026575419913: Tibia Component - fixed bearing, PS, monoblock
• 04026575419906: Tibia Component - fixed bearing, PS, monoblock
• 04026575419678: Femoral Component - posterior stabilized
• 04026575419661: Femoral Component - posterior stabilized
• 04026575419654: Femoral Component - posterior stabilized
• 04026575419647: Femoral Component - posterior stabilized
• 04026575419630: Femoral Component - posterior stabilized
• 04026575419623: Femoral Component - posterior stabilized
• 04026575419616: Femoral Component - posterior stabilized
• 04026575419609: Femoral Component - posterior stabilized
• 04026575419593: Femoral Component - posterior stabilized
• 04026575419586: Femoral Component - posterior stabilized
• 04026575419579: Femoral Component - posterior stabilized
• 04026575419562: Femoral Component - posterior stabilized
• 04026575419555: Femoral Component - posterior stabilized
• 04026575419548: Femoral Component - posterior stabilized
• 04026575419531: Femoral Component - posterior stabilized
• 04026575419524: Femoral Component - posterior stabilized
• 04026575419517: Femoral Component
• 04026575419500: Femoral Component
• 04026575419494: Femoral Component
• 04026575419487: Femoral Component
• 04026575419470: Femoral Component
• 04026575419463: Femoral Component
• 04026575419456: Femoral Component
• 04026575419449: Femoral Component
• 04026575419432: Femoral Component
• 04026575419425: Femoral Component
• 04026575419418: Femoral Component
• 04026575419401: Femoral Component
• 04026575419395: Femoral Component
• 04026575419388: Femoral Component
• 04026575419371: Femoral Component
• 04026575419364: Femoral Component
• 04026575417322: Femoral Component - posterior stabilized
• 04026575417315: Femoral Component - posterior stabilized
• 04026575417308: Femoral Component
• 04026575417292: Femoral Component
• 04026575412259: Tibia Component - fixed bearing, posterior Stabili
• 04026575412242: Tibia Component - fixed bearing, posterior Stabili
• 04026575412235: Tibia Component - fixed bearing, posterior Stabili
• 04026575412228: Tibia Component - fixed bearing, posterior Stabili