POLYAX®FEMORAL PLATE - LEFT 148605018
GUDID 00887868015632
Biomet Orthopedics, LLC
Orthopaedic fixation plate, non-bioabsorbable, sterile| Primary Device ID | 00887868015632 |
| NIH Device Record Key | a92fde6e-41c2-46be-b9b8-82ecc27b8c71 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | POLYAX®FEMORAL PLATE - LEFT |
| Version Model Number | 1486-05-018 |
| Catalog Number | 148605018 |
| 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 |
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| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| 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 | 00887868015632 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K060969
FDA Product Code
| HRS | PLATE, FIXATION, BONE |
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 [POLYAX®FEMORAL PLATE - LEFT]
| 00887868015632 | 1486-05-018 |
| 00887868015625 | 1486-05-015 |
| 00887868015618 | 1486-05-012 |
| 00887868015601 | 1486-05-009 |
| 00887868015595 | 1486-05-006 |
| 00887868036972 | 8141-31-118 |
| 00887868036965 | 8141-31-115 |
| 00887868036958 | 8141-31-112 |
| 00887868036941 | 8141-31-109 |
| 00887868036934 | 8141-31-106 |
Trademark Results [POLYAX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 POLYAX 78464561 3181622 Live/Registered |
BIOMET C.V. 2004-08-09 |
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