DELTA Multihole TT Pro 5554.14.523

GUDID 08033390151207

Acetabular Cup Dia. 52 mm (Liner #MEDIUM+)

LIMACORPORATE SPA

Metallic acetabulum prosthesis Metallic acetabulum prosthesis Metallic acetabulum prosthesis Metallic acetabulum prosthesis Metallic acetabulum prosthesis Metallic acetabulum prosthesis Metallic acetabulum prosthesis Metallic acetabulum prosthesis Metallic acetabulum prosthesis Metallic acetabulum prosthesis Metallic acetabulum prosthesis Metallic acetabulum prosthesis Metallic acetabulum prosthesis Metallic acetabulum prosthesis Metallic acetabulum prosthesis Metallic acetabulum prosthesis Metallic acetabulum prosthesis Metallic acetabulum prosthesis

• Primary Device ID: 08033390151207
• NIH Device Record Key: 53717fbc-5b93-438a-b881-98ae91de8ef5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DELTA Multihole TT Pro
• Version Model Number: 5554.14.523
• Catalog Number: 5554.14.523
• Company DUNS: 432066322
• Company Name: LIMACORPORATE SPA
• 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	08033390151207 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191622

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: 2019-11-18
• Device Publish Date: 2019-11-09

On-Brand Devices [DELTA Multihole TT Pro]

• 08033390151498: Acetabular Cup Dia. 76 mm (Liner # 2 EXTRA-LARGE)
• 08033390151481: Acetabular Cup Dia. 74 mm (Liner # 2 EXTRA-LARGE)
• 08033390151474: Acetabular Cup Dia. 72 mm (Liner # 2 EXTRA-LARGE)
• 08033390151467: Acetabular Cup Dia. 70 mm (Liner # 2 EXTRA-LARGE)
• 08033390151450: Acetabular Cup Dia. 68 mm (Liner # 2 EXTRA-LARGE)
• 08033390151443: Acetabular Cup Dia. 66 mm (Liner #EXTRA-LARGE)
• 08033390151436: Acetabular Cup Dia. 64 mm (Liner #EXTRA-LARGE)
• 08033390151429: Acetabular Cup Dia. 62 mm (Liner #EXTRA-LARGE)
• 08033390151412: Acetabular Cup Dia. 60 mm (Liner #EXTRA-LARGE)
• 08033390151405: Acetabular Cup Dia. 58 mm (Liner #LARGE+)
• 08033390151399: Acetabular Cup Dia. 56 mm (Liner #LARGE+)
• 08033390151382: Acetabular Cup Dia. 54 mm (Liner #MEDIUM+)
• 08033390151207: Acetabular Cup Dia. 52 mm (Liner #MEDIUM+)
• 08033390151191: Acetabular Cup Dia. 50 mm (Liner #MEDIUM+)
• 08033390151184: Acetabular Cup Dia. 48 mm (Liner #MEDIUM-)
• 08033390151115: Acetabular Cup Dia. 46 mm (Liner #MEDIUM-)
• 08033390151108: Acetabular Cup Dia. 44 mm (Liners #SMALL)