DELTA SYSTEM 9095.11.551

GUDID 08033390152310

Curved Cup Impactor Reduced Offset

LIMACORPORATE SPA

Orthopaedic implant impactor

• Primary Device ID: 08033390152310
• NIH Device Record Key: b1fcd35e-854f-4991-b238-66211bddd070
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DELTA SYSTEM
• Version Model Number: 9095.11.551
• Catalog Number: 9095.11.551
• 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: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	08033390152310 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112898

FDA Product Code

• MBL: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08033390152310]

Moist Heat or Steam Sterilization

[08033390152310]

Moist Heat or Steam Sterilization

[08033390152310]

Moist Heat or Steam Sterilization

[08033390152310]

Moist Heat or Steam Sterilization

[08033390152310]

Moist Heat or Steam Sterilization

[08033390152310]

Moist Heat or Steam Sterilization

[08033390152310]

Moist Heat or Steam Sterilization

[08033390152310]

Moist Heat or Steam Sterilization

[08033390152310]

Moist Heat or Steam Sterilization

[08033390152310]

Moist Heat or Steam Sterilization

[08033390152310]

Moist Heat or Steam Sterilization

[08033390152310]

Moist Heat or Steam Sterilization

[08033390152310]

Moist Heat or Steam Sterilization

[08033390152310]

Moist Heat or Steam Sterilization

[08033390152310]

Moist Heat or Steam Sterilization

[08033390152310]

Moist Heat or Steam Sterilization

[08033390152310]

Moist Heat or Steam Sterilization

[08033390152310]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-03
• Device Publish Date: 2019-06-25

Devices Manufactured by LIMACORPORATE SPA

• 08033390269094 - MASTER SL Stem: 2025-08-15 MASTER SL Stem - Standard - Taper 12/14 #1 H.96mm
• 08033390269117 - MASTER SL Stem: 2025-08-15 MASTER SL Stem - Lateralized - Taper 12/14 #1 H.96mm
• 08033390269155 - H-MAX S Stem: 2025-08-15 H-MAX S Stem - Standard - Taper 12/14 #8 H.130mm
• 08033390269162 - H-MAX S Stem: 2025-08-15 H-MAX S Stem - Lateralized - Taper 12/14 #8 H.130mm
• 08033390269254 - C2 Stem: 2025-08-15 C2 Stem - Standard - Taper 12/14 #01 H.128mm
• 08033390269261 - C2 Stem: 2025-08-15 C2 Stem - Lateralized - Taper 12/14 #01 H.128mm
• 08033390298483 - MASTER SL Stem: 2025-08-15 MASTER SL Stem - Standard - Taper 12/14 #2 H.123mm
• 08033390298490 - MASTER SL Stem: 2025-08-15 MASTER SL Stem - Standard - Taper 12/14 #3 H.126mm