Duracon 6642-2-200

GUDID 04546540318398

Asymmetric Patella

Howmedica Osteonics Corp.

Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis

• Primary Device ID: 04546540318398
• NIH Device Record Key: dcb376f2-447f-4ef3-ac18-04eda395216a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Duracon
• Version Model Number: 6642-2-200
• Catalog Number: 6642-2-200
• 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 Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540318398 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000091

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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