System 12 C-M108-1-000

GUDID 07613327422603

Constrained Acetabular Insert

Howmedica Osteonics Corp.

Constrained polyethylene acetabular liner

• Primary Device ID: 07613327422603
• NIH Device Record Key: 9e3ba834-ef00-4d80-bb14-de318555549c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: System 12
• Version Model Number: C-M108-1-000
• Catalog Number: C-M108-1-000
• 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
• Lumen/Inner Diameter: 28 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327422603 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063550

FDA Product Code

• KWZ: Prosthesis, hip, constrained, cemented or uncemented, 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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-12

On-Brand Devices [System 12]

• 07613327461640: Constrained Acetabular Insert
• 07613327455779: Constrained Acetabular Insert
• 07613327422603: Constrained Acetabular Insert
• 07613327139242: Constrained Acetabular Insert
• 07613327139228: Constrained Acetabular Insert
• 07613327139174: Constrained Acetabular Insert
• 07613327139150: Constrained Acetabular Insert
• 07613327139143: Constrained Acetabular Insert
• 07613327139136: Constrained Acetabular Insert
• 07613327139129: Constrained Acetabular Insert
• 07613327139112: Constrained Acetabular Insert
• 07613327139105: Constrained Acetabular Insert
• 07613327139099: Constrained Acetabular Insert
• 07613327139082: Constrained Acetabular Insert
• 07613327139075: Constrained Acetabular Insert
• 07613327139068: Constrained Acetabular Insert
• 07613327139051: Constrained Acetabular Insert
• 07613327139044: Constrained Acetabular Insert
• 07613327139037: Constrained Acetabular Insert
• 07613327139020: Constrained Acetabular Insert
• 07613327139013: Constrained Acetabular Insert
• 07613327139006: Constrained Acetabular Insert
• 07613327138993: Constrained Acetabular Insert
• 07613327138986: Constrained Acetabular Insert
• 07613327138979: Constrained Acetabular Insert
• 07613327138962: Constrained Acetabular Insert
• 07613327138955: Constrained Acetabular Insert
• 07613327138948: Constrained Acetabular Insert
• 07613327138931: Constrained Acetabular Insert
• 07613327138924: Constrained Acetabular Insert
• 07613327138917: Constrained Acetabular Insert
• 07613327138900: Constrained Acetabular Insert
• 07613327138894: Constrained Acetabular Insert
• 07613327138887: Constrained Acetabular Insert
• 07613327138863: Constrained Acetabular Insert
• 07613327138856: Constrained Acetabular Insert
• 07613327138849: Constrained Acetabular Insert
• 07613327138832: Constrained Acetabular Insert
• 07613327138825: Constrained Acetabular Insert
• 07613327138818: Constrained Acetabular Insert
• 07613327138801: Constrained Acetabular Insert
• 07613327138771: Constrained Acetabular Insert
• 07613327138764: Constrained Acetabular Insert
• 07613327101843: Lateralizing Insert
• 07613327101836: Lateralizing Insert
• 07613327101829: Lateralizing Insert
• 07613327101812: Lateralizing Insert
• 07613327038781: 10 Degree Polyethylene Insert
• 07613327038774: 10 Degree Polyethylene Insert
• 07613327038767: 10 Degree Polyethylene Insert