VANGUARD® COMPLETE KNEE SYSTEM 195577
GUDID 00880304990661
Biomet Orthopedics, LLC
Uncoated knee tibia/insert prosthesis Uncoated knee tibia/insert prosthesis Uncoated knee tibia/insert prosthesis Uncoated knee tibia/insert prosthesis Uncoated knee tibia/insert prosthesis Uncoated knee tibia/insert prosthesis Uncoated knee tibia/insert prosthesis Uncoated knee tibia/insert prosthesis Uncoated knee tibia/insert prosthesis Uncoated knee tibia/insert prosthesis| Primary Device ID | 00880304990661 |
| NIH Device Record Key | cd7e6bf5-8d45-47c2-9bef-0a6bc828e4eb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VANGUARD® COMPLETE KNEE SYSTEM |
| Version Model Number | 195577 |
| Catalog Number | 195577 |
| 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 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00880304990661 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K132873
FDA Product Code
| MBV | Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, 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 | 2017-07-28 |
On-Brand Devices [VANGUARD® COMPLETE KNEE SYSTEM]
Trademark Results [VANGUARD]
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