LinkSymphoKnee 880-207/14

GUDID 04026575252497

Articulating Surfaces, CR

WALDEMAR LINK GmbH & Co. KG

Uncoated knee tibia prosthesis, polyethylene

• Primary Device ID: 04026575252497
• NIH Device Record Key: 4e60b7c4-5398-454a-b59a-235f60f9fe41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LinkSymphoKnee
• Version Model Number: 880-207/14
• Catalog Number: 880-207/14
• 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: 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	04026575252497 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202924

FDA Product Code

• KRO: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, 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: 2021-10-15
• Device Publish Date: 2021-10-07

On-Brand Devices [LinkSymphoKnee]

• 04026575443949: Modular Stem, Cylindrical Press-Fit
• 04026575443932: Modular Stem, Cylindrical Press-Fit
• 04026575443925: Modular Stem, Cylindrical Press-Fit
• 04026575320042: Tibial Cutting Block Valgus re-cut
• 04026575315611: Offset Selector, CCK
• 04026575313365: Tibial Cutting Block Varus re-cut
• 04026575313297: Tibial Cutting Block, 8° Right
• 04026575313273: Tibial Cutting Block, 8° Left
• 04026575313259: Tibial Cutting Block, 3° Right
• 04026575313235: Tibial Cutting Block, 3° Left
• 04026575305889: Femoral Box Guide, CCK, Size 9-10
• 04026575305865: Femoral Box Guide, CCK, Size 7-8
• 04026575305827: Femoral Box Guide, CCK, Size 5-6
• 04026575305803: Femoral Box Guide, CCK, Size 3-4
• 04026575305766: Femoral Box Guide, CCK, Size 0-1-2
• 04026575305650: Femoral PS Box Guide, Size 10
• 04026575305643: Femoral PS Box Guide, Size 9
• 04026575305629: Femoral PS Box Guide, Size 8
• 04026575305605: Femoral PS Box Guide, Size 7
• 04026575305582: Femoral PS Box Guide, Size 6
• 04026575305551: Femoral PS Box Guide, Size 5+
• 04026575305537: Femoral PS Box Guide, Size 5
• 04026575305520: Femoral PS Box Guide, Size 4+
• 04026575305506: Femoral PS Box Guide, Size 4
• 04026575305483: Femoral PS Box Guide, Size 3+
• 04026575305469: Femoral PS Box Guide, Size 3
• 04026575305445: Femoral PS Box Guide, Size 2
• 04026575305421: Femoral PS Box Guide, Size 1
• 04026575305407: Femoral PS Box Guide, Size 0
• 04026575305384: Femoral Cutting Block, CCK, 4-in-1 Cut, Size 10
• 04026575305360: Femoral Cutting Block, CCK, 4-in-1 Cut, Size 9
• 04026575305339: Femoral Cutting Block, CCK, 4-in-1 Cut, Size 8
• 04026575305315: Femoral Cutting Block, CCK, 4-in-1 Cut, Size 7
• 04026575305292: Femoral Cutting Block, CCK, 4-in-1 Cut, Size 6
• 04026575305278: Femoral Cutting Block, CCK, 4-in-1 Cut, Size 5
• 04026575305261: Femoral Cutting Block, CCK, 4-in-1 Cut, Size 4
• 04026575305254: Femoral Cutting Block, CCK, 4-in-1 Cut, Size 3
• 04026575305230: Femoral Cutting Block, CCK, 4-in-1 Cut, Size 2
• 04026575305216: Femoral Cutting Block, CCK, 4-in-1 Cut, Size 1
• 04026575305193: Femoral Cutting Block, CCK, 4-in-1 Cut, Size 0
• 04026575305179: Femoral Cutting Block, 4-in-1 Cut, Size 10
• 04026575305162: Femoral Cutting Block, 4-in-1 Cut, Size 9
• 04026575305155: Posterior Reference, Femoral Cutting Block, 4-in-1
• 04026575305131: Posterior Reference, Femoral Cutting Block, 4-in-1
• 04026575305117: Posterior Reference, Femoral Cutting Block, 4-in-1
• 04026575305094: Posterior Reference, Femoral Cutting Block, 4-in-1
• 04026575305070: Posterior Reference, Femoral Cutting Block, 4-in-1
• 04026575305056: Posterior Reference, Femoral Cutting Block, 4-in-1
• 04026575305032: Femoral Cutting Block, 4-in-1 Cut, Size 2
• 04026575305018: Femoral Cutting Block, 4-in-1 Cut, Size 1