DELTA Multihole TT Pro 5554.14.523

GUDID 08033390151207

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

LIMACORPORATE SPA

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)