Shoulder - TiNbN Coating

GUDID 07630345708861

SensiTiN Metal humeral head Ø56

Medacta International SA

Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis

• Primary Device ID: 07630345708861
• NIH Device Record Key: 365eb0c6-c8cd-4af5-813b-3179c45d567a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shoulder - TiNbN Coating
• Version Model Number: 04.01.0264
• 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	07630345708861 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203755

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-18
• Device Publish Date: 2021-03-10

On-Brand Devices [Shoulder - TiNbN Coating]

• 07630345709059: SensiTiN Lat. Glenosphere 42xØ27
• 07630345709042: SensiTiN Lat. Glenosphere 39xØ27
• 07630345709035: SensiTiN Lat. Glenosphere 36xØ27
• 07630345709028: SensiTiN Lat. Glenosphere 42xØ24.5
• 07630345709011: SensiTiN Lat. Glenosphere 39xØ24.5
• 07630345709004: SensiTiN Lat. Glenosphere 36xØ24.5
• 07630345708991: SensiTiN Lat. Glenosphere 32xØ24.5
• 07630345708984: SensiTiN Lat. Glenosphere 36xØ22
• 07630345708977: SensiTiN Lat. Glenosphere 32xØ22
• 07630345708960: SensiTiN Glenosphere 42xØ27
• 07630345708953: SensiTiN Glenosphere 39xØ27
• 07630345708946: SensiTiN Glenosphere 36xØ27
• 07630345708939: SensiTiN Glenosphere 42xØ24.5
• 07630345708922: SensiTiN Glenosphere 39xØ24.5
• 07630345708915: SensiTiN Glenosphere 36xØ24.5
• 07630345708908: SensiTiN Glenosphere 32xØ24.5
• 07630345708892: SensiTiN Glenosphere 36xØ22
• 07630345708885: SensiTiN Glenosphere 32xØ22
• 07630345708878: SensiTiN Metal humeral head Ø58
• 07630345708861: SensiTiN Metal humeral head Ø56
• 07630345708854: SensiTiN Metal humeral head Ø54
• 07630345708847: SensiTiN Metal humeral head Ø52
• 07630345708830: SensiTiN Metal humeral head Ø50
• 07630345708823: SensiTiN Metal humeral head Ø48
• 07630345708816: SensiTiN Metal humeral head Ø46
• 07630345708809: SensiTiN Metal humeral head Ø44
• 07630345708793: SensiTiN Metal humeral head Ø42
• 07630345708786: SensiTiN Metal humeral head Ø40