Mallory-Head® Primary Hip System 11-104108
GUDID 00887868307713
Biomet Orthopedics, LLC
Coated hip femur prosthesis, modular| Primary Device ID | 00887868307713 |
| NIH Device Record Key | f9c1b493-2e74-4753-a583-e7d823a53afe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mallory-Head® Primary Hip System |
| Version Model Number | 11-104108 |
| Catalog Number | 11-104108 |
| 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
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com |
Device Dimensions
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887868307713 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K030055
FDA Product Code
| LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED |
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 | 2019-04-26 |
| Device Publish Date | 2019-04-18 |
On-Brand Devices [Mallory-Head® Primary Hip System]
Trademark Results [Mallory-Head]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MALLORY-HEAD 73737255 1522518 Live/Registered |
BIOMET, INC. 1988-06-29 |
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