Duracon 6637-0-128

GUDID 04546540305923

Cemented Modular Insert

Howmedica Osteonics Corp.

Tibial insert

• Primary Device ID: 04546540305923
• NIH Device Record Key: e7df42e7-5199-47e0-8d71-367aa06fd70a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Duracon
• Version Model Number: 6637-0-128
• Catalog Number: 6637-0-128
• Company DUNS: 058311945
• Company Name: Howmedica Osteonics Corp.
• 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: 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540305923 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K940861

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [Duracon]

• 07613327141283: Tibial Bearing Insert - CS
• 07613327101904: Inset Patella
• 07613327101867: Inset Patella
• 07613327101850: Asymmetric Patella
• 07613327050271: Total Stabilizer Offset Adapter
• 07613327050264: Total Stabilizer Offset Adapter
• 07613327050257: Total Stabilizer Offset Adapter
• 07613327050042: Total Stabilizer Offset Adapter
• 07613327049701: Lipped Tibial Insert
• 07613327049695: Lipped Tibial Insert
• 07613327049688: Lipped Tibial Insert
• 07613327049671: Lipped Tibial Insert
• 07613327049664: Lipped Tibial Insert
• 07613327049657: Lipped Tibial Insert
• 07613327049640: Lipped Tibial Insert
• 07613327049633: Lipped Tibial Insert
• 07613327049626: Lipped Tibial Insert
• 07613327049619: Lipped Tibial Insert
• 07613327049602: Lipped Tibial Insert
• 07613327049596: Lipped Tibial Insert
• 07613327049589: Lipped Tibial Insert
• 07613327049572: Lipped Tibial Insert
• 07613327049565: Lipped Tibial Insert
• 07613327049558: Lipped Tibial Insert
• 07613327049541: Lipped Tibial Insert
• 07613327049534: Lipped Tibial Insert
• 07613327049527: Lipped Tibial Insert
• 07613327049510: Lipped Tibial Insert
• 07613327049503: Lipped Tibial Insert
• 07613327049497: Lipped Tibial Insert
• 07613327049480: Lipped Tibial Insert
• 07613327049473: Lipped Tibial Insert
• 07613327049466: Lipped Tibial Insert
• 07613327049459: Lipped Tibial Insert
• 07613327049442: Lipped Tibial Insert
• 07613327049435: Lipped Tibial Insert
• 07613327049428: Lipped Tibial Insert
• 07613327049411: Lipped Tibial Insert
• 07613327049398: Lipped Tibial Insert
• 07613327049381: Lipped Tibial Insert
• 07613327048926: Tibial Bearing Insert
• 07613327048902: Tibial Bearing Insert
• 07613327048889: Metal Backed Symmetric Patella
• 07613327048872: Distal Femoral Fixation Pegs
• 07613327045086: Titanium Fluted Stem
• 07613327045079: Titanium Fluted Stem
• 07613327045062: Titanium Fluted Stem
• 07613327045055: Titanium Fluted Stem
• 07613327045048: Titanium Fluted Stem
• 07613327045031: Titanium Fluted Stem