Vanguard® Knee System 184764
GUDID 00887868344084
Biomet Orthopedics, LLC
Polyethylene patella prosthesis| Primary Device ID | 00887868344084 |
| NIH Device Record Key | e6e6200f-8fd5-4eb1-972e-d793f64c348e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vanguard® Knee System |
| Version Model Number | 184764 |
| Catalog Number | 184764 |
| Company DUNS | 129278169 |
| Company Name | Biomet Orthopedics, LLC |
| 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 |
Customer Support Contacts
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 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 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 | 00887868344084 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K040770
FDA Product Code
| OIY | Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive |
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 | 2019-10-21 |
| Device Publish Date | 2019-10-11 |
On-Brand Devices [Vanguard® Knee System]
| 00887868344220 | 184795 |
| 00887868344213 | 184794 |
| 00887868344206 | 184793 |
| 00887868344190 | 184792 |
| 00887868344183 | 184791 |
| 00887868344176 | 184790 |
| 00887868344169 | 184788 |
| 00887868344152 | 184786 |
| 00887868344145 | 184784 |
| 00887868344138 | 184782 |
| 00887868344121 | 184780 |
| 00887868344114 | 184770 |
| 00887868344107 | 184768 |
| 00887868344091 | 184766 |
| 00887868344084 | 184764 |
| 00887868344077 | 184762 |
| 00887868344060 | 184760 |
| 00887868344053 | 184728 |
| 00887868344046 | 184726 |
| 00887868344039 | 184724 |
| 00887868344022 | 184722 |
| 00887868344015 | 184720 |
| 00887868344008 | 184710 |
| 00887868343995 | 184708 |
| 00887868343988 | 184706 |
| 00887868343971 | 184704 |
| 00887868343964 | 184702 |
| 00887868343957 | 184700 |
| 00887868227592 | 183099 |
| 00887868246555 | 183621 |
| 00880304653450 | CP113593 |
| 00880304653443 | CP113592 |
Trademark Results [Vanguard]
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