Shoulder - TiNbN Coating

GUDID 07630345709035

SensiTiN Lat. Glenosphere 36xØ27

Medacta International SA

Total shoulder prosthesis

• Primary Device ID: 07630345709035
• NIH Device Record Key: 37ec34ca-81bf-4bad-8d57-e246b46e8b58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shoulder - TiNbN Coating
• Version Model Number: 04.01.0281
• 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	07630345709035 [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