Insignia 7000-6608

GUDID 07613327511628

Hip Stem - High Offset

Howmedica Osteonics Corp.

Coated hip femur prosthesis, modular

• Primary Device ID: 07613327511628
• NIH Device Record Key: 18641487-fa3c-4376-a199-f2c999aff77a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Insignia
• Version Model Number: 7000-6608
• Catalog Number: 7000-6608
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327511628 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211703

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-09
• Device Publish Date: 2021-12-01

On-Brand Devices [Insignia]

• 07613327511628: Hip Stem - High Offset
• 07613327511611: Hip Stem - Standard Offset
• 07613327511604: Hip Stem - Standard Offset
• 07613327511598: Hip Stem - High Offset
• 07613327511581: Hip Stem - Standard Offset
• 07613327511574: Hip Stem - Standard Offset
• 07613327511567: Hip Stem - Standard Offset
• 07613327511550: Hip Stem - Standard Offset
• 07613327511543: Hip Stem - High Offset
• 07613327511536: Hip Stem - High Offset
• 07613327511529: Hip Stem - Standard Offset
• 07613327511512: Hip Stem - High Offset
• 07613327511505: Hip Stem - High Offset
• 07613327511499: Hip Stem - High Offset
• 07613327511482: Hip Stem - High Offset
• 07613327511475: Hip Stem - High Offset
• 07613327511468: Hip Stem - High Offset
• 07613327511451: Hip Stem - High Offset
• 07613327511444: Hip Stem - Standard Offset
• 07613327511437: Hip Stem - Standard Offset
• 07613327511420: Hip Stem - Standard Offset
• 07613327511413: Hip Stem - Standard Offset
• 07613327511406: Hip Stem - High Offset
• 07613327511390: Hip Stem - Standard Offset