Masterloc Femoral Stems

GUDID 07630040731386

Cementless Ti Coated LAT Stem # 13

Medacta International SA

Press-fit hip femur prosthesis, one-piece

• Primary Device ID: 07630040731386
• NIH Device Record Key: 6e9ea8c8-959a-4529-8853-47484f8d5b2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Masterloc Femoral Stems
• Version Model Number: 01.39.213
• Company DUNS: 488227125
• Company Name: Medacta International SA
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	07630040731386 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191145

FDA Product Code

• LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-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: 2019-06-13
• Device Publish Date: 2019-06-05

On-Brand Devices [Masterloc Femoral Stems]

• 07630030885723: Masterloc Cementless Ti Coated LAT Stem # 12
• 07630030885716: Masterloc Cementless Ti Coated LAT Stem # 11
• 07630030885709: Masterloc Cementless Ti Coated LAT Stem # 10
• 07630030885693: Masterloc Cementless Ti Coated LAT Stem # 9
• 07630030885686: Masterloc Cementless Ti Coated LAT Stem # 8
• 07630030885679: Masterloc Cementless Ti Coated LAT Stem # 7
• 07630030885662: Masterloc Cementless Ti Coated LAT Stem # 6
• 07630030885655: Masterloc Cementless Ti Coated LAT Stem # 5
• 07630030885648: Masterloc Cementless Ti Coated LAT Stem # 4
• 07630030885631: Masterloc Cementless Ti Coated LAT Stem # 3
• 07630030885624: Masterloc Cementless Ti Coated LAT Stem # 2
• 07630030885617: Masterloc Cementless Ti Coated STD Stem # 12
• 07630030885600: Masterloc Cementless Ti Coated STD Stem # 11
• 07630030885594: Masterloc Cementless Ti Coated STD Stem # 10
• 07630030885587: Masterloc Cementless Ti Coated STD Stem # 9
• 07630030885570: Masterloc Cementless Ti Coated STD Stem # 8
• 07630030885563: Masterloc Cementless Ti Coated STD Stem # 7
• 07630030885556: Masterloc Cementless Ti Coated STD Stem # 6
• 07630030885549: Masterloc Cementless Ti Coated STD Stem # 5
• 07630030885532: Masterloc Cementless Ti Coated STD Stem # 4
• 07630030885525: Masterloc Cementless Ti Coated STD Stem # 3
• 07630030885518: Masterloc Cementless Ti Coated STD Stem # 2
• 07630030861284: Masterloc Cementless Ti Coated LAT Stem # 1
• 07630030861260: Masterloc Cementless Ti Coated STD Stem # 1
• 07630040731393: Cementless Ti Coated LAT Stem # 14
• 07630040731386: Cementless Ti Coated LAT Stem # 13