VANGUARD SSK 360 KNEE SYSTEM 185168

GUDID 00880304481367

Biomet Orthopedics, LLC

Tibial insert

• Primary Device ID: 00880304481367
• NIH Device Record Key: b11379da-3912-4596-9702-bfe2b545548f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VANGUARD SSK 360 KNEE SYSTEM
• Version Model Number: 185168
• Catalog Number: 185168
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Customer Support Contacts

• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304481367 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093293

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

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: 2015-10-24

On-Brand Devices [VANGUARD SSK 360 KNEE SYSTEM]

• 00880304481398: 185174
• 00880304481381: 185172
• 00880304481374: 185170
• 00880304481367: 185168
• 00880304481350: 185166
• 00880304481343: 185164
• 00880304481336: 185162
• 00880304481329: 185160
• 00880304481312: 185154
• 00880304481305: 185152
• 00880304481299: 185150
• 00880304481282: 185148
• 00880304481275: 185146
• 00880304481268: 185144
• 00880304481251: 185142
• 00880304467408: 185140