PCA 6299-H-428

GUDID 07613327138689

Constrained Acetabular Insert

Howmedica Osteonics Corp.

Constrained polyethylene acetabular liner

• Primary Device ID: 07613327138689
• NIH Device Record Key: 3b8a582a-9749-4bb9-80b4-f08e9aee5327
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PCA
• Version Model Number: 6299-H-428
• Catalog Number: 6299-H-428
• 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
• Lumen/Inner Diameter: 28 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327138689 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063445

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [PCA]

• 07613327455809: Constrained Acetabular Insert
• 07613327138870: Constrained Acetabular Insert
• 07613327138795: Constrained Acetabular Insert
• 07613327138788: Constrained Acetabular Insert
• 07613327138757: Constrained Acetabular Insert
• 07613327138733: Constrained Acetabular Insert
• 07613327138726: Constrained Acetabular Insert
• 07613327138719: Constrained Acetabular Insert
• 07613327138702: Constrained Acetabular Insert
• 07613327138696: Constrained Acetabular Insert
• 07613327138689: Constrained Acetabular Insert
• 07613327138672: Constrained Acetabular Insert
• 07613327138665: Constrained Acetabular Insert
• 07613327138658: Constrained Acetabular Insert
• 07613327138641: Constrained Acetabular Insert
• 07613327138634: Skirtless 2 Degree 52' Taper Head
• 07613327138627: Constrained Acetabular Insert
• 07613327138610: Constrained Acetabular Insert
• 07613327138603: Constrained Acetabular Insert
• 07613327138597: Constrained Acetabular Insert
• 07613327138580: Skirtless 2 Degree 52' Taper Head
• 07613327138573: Constrained Acetabular Insert
• 07613327138566: Constrained Acetabular Insert
• 07613327138542: Constrained Acetabular Insert
• 07613327138535: Skirtless 2 Degree 52' Taper Head
• 07613327138528: Constrained Acetabular Insert
• 07613327138511: Skirtless 2 Degree 52' Taper Head
• 07613327138320: Constrained Acetabular Insert
• 07613327138276: Skirted 2 Degree 52' Taper Head
• 07613327138252: Constrained Acetabular Insert