Anatomic Shoulder Prosthesis

GUDID 07630040713016

Humeral Anatomical Metaphysis – Cemented, Size 8, 128°

Medacta International SA

Total shoulder prosthesis

• Primary Device ID: 07630040713016
• NIH Device Record Key: 9a141d09-7113-459e-933a-3cbc1921805a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anatomic Shoulder Prosthesis
• Version Model Number: 04.01.0069
• 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	07630040713016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170910

FDA Product Code

• KWS: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-08-24

On-Brand Devices [Anatomic Shoulder Prosthesis]

• 07630040713337: Humeral Stem Screw
• 07630040713320: Highcross PE Pegged Glenoid, Size Ø 58 mm
• 07630040713313: Highcross PE Pegged Glenoid, Size Ø 56 mm
• 07630040713306: Highcross PE Pegged Glenoid, Size Ø 54 mm
• 07630040713290: Highcross PE Pegged Glenoid, Size Ø 52 mm
• 07630040713283: Highcross PE Pegged Glenoid, Size Ø 450 mm
• 07630040713276: Highcross PE Pegged Glenoid, Size Ø 48 mm
• 07630040713269: Highcross PE Pegged Glenoid, Size Ø 46 mm
• 07630040713252: Highcross PE Pegged Glenoid, Size Ø 44 mm
• 07630040713245: Highcross PE Pegged Glenoid, Size Ø 42 mm
• 07630040713238: Highcross PE Pegged Glenoid, Size Ø 40 mm
• 07630040713221: Cobalt-Chromium Humeral Head, Size Ø 58 mm
• 07630040713214: Cobalt-Chromium Humeral Head, Size Ø 56 mm
• 07630040713207: Cobalt-Chromium Humeral Head, Size Ø 54 mm
• 07630040713191: Cobalt-Chromium Humeral Head, Size Ø 52 mm
• 07630040713184: Cobalt-Chromium Humeral Head, Size Ø 50 mm
• 07630040713177: Cobalt-Chromium Humeral Head, Size Ø 48 mm
• 07630040713160: Cobalt-Chromium Humeral Head, Size Ø 46 mm
• 07630040713153: Cobalt-Chromium Humeral Head, Size Ø 44 mm
• 07630040713146: Cobalt-Chromium Humeral Head, Size Ø 42 mm
• 07630040713139: Cobalt-Chromium Humeral Head, Size Ø 40 mm
• 07630040713122: Double Eccenter
• 07630040713115: Humeral Anatomical Metaphysis – Cemented, Size 16, 142°
• 07630040713108: Humeral Anatomical Metaphysis – Cemented, Size 14, 142°
• 07630040713092: Humeral Anatomical Metaphysis – Cemented, Size 12, 142°
• 07630040713085: Humeral Anatomical Metaphysis – Cemented, Size 10, 142°
• 07630040713078: Humeral Anatomical Metaphysis – Cemented, Size 8, 142°
• 07630040713061: Humeral Anatomical Metaphysis – Cemented, Size 6, 142°
• 07630040713054: Humeral Anatomical Metaphysis – Cemented, Size 16, 128°
• 07630040713047: Humeral Anatomical Metaphysis – Cemented, Size 14, 128°
• 07630040713030: Humeral Anatomical Metaphysis – Cemented, Size 12, 128°
• 07630040713023: Humeral Anatomical Metaphysis – Cemented, Size 10, 128°
• 07630040713016: Humeral Anatomical Metaphysis – Cemented, Size 8, 128°
• 07630040713009: Humeral Anatomical Metaphysis – Cemented, Size 6, 128°
• 07630040712996: Humeral Anatomical Metaphysis – Cemented, Size 16, 135°
• 07630040712989: Humeral Anatomical Metaphysis – Cemented, Size 14, 135°
• 07630040712972: Humeral Anatomical Metaphysis – Cemented, Size 12, 135°
• 07630040712965: Humeral Anatomical Metaphysis – Cemented, Size 10, 135°
• 07630040712958: Humeral Anatomical Metaphysis – Cemented, Size 8, 135°
• 07630040712941: Humeral Anatomical Metaphysis – Cemented, Size 6, 135°
• 07630040712934: Humeral Anatomical Metaphysis – Cementless, Size 16, 142°
• 07630040712927: Humeral Anatomical Metaphysis – Cementless, Size 15, 142°
• 07630040712910: Humeral Anatomical Metaphysis – Cementless, Size 14, 142°
• 07630040712903: Humeral Anatomical Metaphysis – Cementless, Size 13, 142°
• 07630040712897: Humeral Anatomical Metaphysis – Cementless, Size 12, 142°
• 07630040712880: Humeral Anatomical Metaphysis – Cementless, Size 11, 142°
• 07630040712873: Humeral Anatomical Metaphysis – Cementless, Size 10, 142°
• 07630040712866: Humeral Anatomical Metaphysis – Cementless, Size 9, 142°
• 07630040712859: Humeral Anatomical Metaphysis – Cementless, Size 8, 142°
• 07630040712842: Humeral Anatomical Metaphysis – Cementless, Size 7, 142°