H-MAX S Stem 4250.20.160

GUDID 08033390298957

H-MAX S Stem - Standard - Taper 12/14 #16 H.170mm

LIMACORPORATE SPA

Press-fit femoral stem prosthesis

• Primary Device ID: 08033390298957
• NIH Device Record Key: 854b30da-3cd9-468a-8ca1-02d25e6924bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: H-MAX S Stem
• Version Model Number: 4250.20.160
• Catalog Number: 4250.20.160
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	08033390298957 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160011

FDA Product Code

• KWY: Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or 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: 2025-08-15
• Device Publish Date: 2025-08-07

On-Brand Devices [H-MAX S Stem]

• 08033390299961: H-MAX S Stem - Lateralized - Taper 12/14 #18 H.180mm
• 08033390299954: H-MAX S Stem - Lateralized - Taper 12/14 #17 H.175mm
• 08033390299947: H-MAX S Stem - Lateralized - Taper 12/14 #16 H.170mm
• 08033390299930: H-MAX S Stem - Lateralized - Taper 12/14 #15 H.165mm
• 08033390299923: H-MAX S Stem - Lateralized - Taper 12/14 #14 H.160mm
• 08033390299916: H-MAX S Stem - Lateralized - Taper 12/14 #13 H.155mm
• 08033390299909: H-MAX S Stem - Lateralized - Taper 12/14 #12 H.150mm
• 08033390299893: H-MAX S Stem - Lateralized - Taper 12/14 #11 H.145mm
• 08033390299886: H-MAX S Stem - Lateralized - Taper 12/14 #10 H.140mm
• 08033390299879: H-MAX S Stem - Lateralized - Taper 12/14 #9 H.135mm
• 08033390298971: H-MAX S Stem - Standard - Taper 12/14 #18 H.180mm
• 08033390298964: H-MAX S Stem - Standard - Taper 12/14 #17 H.175mm
• 08033390298957: H-MAX S Stem - Standard - Taper 12/14 #16 H.170mm
• 08033390298940: H-MAX S Stem - Standard - Taper 12/14 #15 H.165mm
• 08033390298933: H-MAX S Stem - Standard - Taper 12/14 #14 H.160mm
• 08033390298926: H-MAX S Stem - Standard - Taper 12/14 #13 H.155mm
• 08033390298919: H-MAX S Stem - Standard - Taper 12/14 #12 H.150mm
• 08033390298902: H-MAX S Stem - Standard - Taper 12/14 #11 H.145mm
• 08033390298896: H-MAX S Stem - Standard - Taper 12/14 #10 H.140mm
• 08033390298889: H-MAX S Stem - Standard - Taper 12/14 #9 H.135mm
• 08033390269162: H-MAX S Stem - Lateralized - Taper 12/14 #8 H.130mm
• 08033390269155: H-MAX S Stem - Standard - Taper 12/14 #8 H.130mm