Series II C-M108-7-600

GUDID 07613327460995

Constrained Acetabular Insert

Howmedica Osteonics Corp.

Constrained polyethylene acetabular liner

• Primary Device ID: 07613327460995
• NIH Device Record Key: 05cd6fa8-a6ea-4211-b966-d90cb309a0c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Series II
• Version Model Number: C-M108-7-600
• Catalog Number: C-M108-7-600
• 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: true
• Manufacturing Date: true
• 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

• Lumen/Inner Diameter: 28 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327460995 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063552

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: 1
• Public Version Date: 2018-10-15
• Device Publish Date: 2018-09-12

On-Brand Devices [Series II]

• 07613327460995: Constrained Acetabular Insert
• 07613327138559: Constrained Acetabular Insert
• 07613327138504: Constrained Acetabular Insert
• 07613327138443: Constrained Acetabular Insert
• 07613327138436: Constrained Acetabular Insert
• 07613327138429: Constrained Acetabular Insert
• 07613327138405: Constrained Acetabular Insert
• 07613327138399: Constrained Acetabular Insert
• 07613327138382: Constrained Acetabular Insert
• 07613327138375: Constrained Acetabular Insert
• 07613327138368: Constrained Acetabular Insert
• 07613327138351: Constrained Acetabular Insert
• 07613327138344: Constrained Acetabular Insert
• 07613327138337: Constrained Acetabular Insert
• 07613327138290: Constrained Acetabular Insert
• 07613327034288: Tibial Bearing Insert
• 07613327034271: Tibial Bearing Insert
• 07613327034264: Tibial Bearing Insert
• 07613327034257: Tibial Bearing Insert
• 07613327034240: Tibial Bearing Insert
• 07613327034233: Tibial Bearing Insert
• 07613327034226: Tibial Bearing Insert
• 07613327034219: Tibial Bearing Insert
• 07613327034202: Tibial Bearing Insert
• 07613327034196: Tibial Bearing Insert
• 07613327034189: Tibial Bearing Insert
• 07613327034172: Tibial Bearing Insert
• 07613327034165: Tibial Bearing Insert
• 07613327034158: Tibial Bearing Insert
• 07613327034141: Tibial Bearing Insert
• 07613327034134: Tibial Bearing Insert
• 07613327034127: Tibial Bearing Insert
• 07613327034110: Tibial Bearing Insert
• 07613327034103: Tibial Bearing Insert
• 07613327034097: Tibial Bearing Insert
• 07613327034080: Tibial Bearing Insert
• 07613327034073: Tibial Bearing Insert
• 07613327034066: Tibial Bearing Insert
• 07613327034059: Tibial Bearing Insert
• 07613327034042: Tibial Bearing Insert
• 07613327034035: Tibial Bearing Insert
• 07613327034028: Tibial Bearing Insert
• 07613327034011: Tibial Bearing Insert
• 07613327034004: Tibial Bearing Insert
• 07613327033991: Tibial Bearing Insert
• 07613327033984: Tibial Bearing Insert
• 07613327033977: Tibial Bearing Insert
• 07613327033960: Tibial Bearing Insert
• 07613327033953: Tibial Bearing Insert
• 07613327033946: Tibial Bearing Insert