Biomet® Hip System 11-363660
GUDID 00887868307935
Biomet Orthopedics, LLC
Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell| Primary Device ID | 00887868307935 |
| NIH Device Record Key | 858e2a39-6846-4d6d-acaa-59048bc1a4e1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Biomet® Hip System |
| Version Model Number | 11-363660 |
| Catalog Number | 11-363660 |
| 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 | 00887868307935 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K032396
FDA Product Code
| JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented |
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 [Biomet® Hip System]
Trademark Results [Biomet]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOMET 79083976 not registered Dead/Abandoned |
VEOLIA WATER TECHNOLOGIES ITALIA S.p.A. 2010-03-23 |
 BIOMET 78703978 3176481 Live/Registered |
ZIMMER, INC. 2005-08-31 |
 BIOMET 78498921 3235830 Dead/Cancelled |
ARKEMA, INC. 2004-10-13 |
 BIOMET 75282520 2301253 Live/Registered |
ZIMMER, INC. 1997-04-10 |
 BIOMET 74722414 not registered Dead/Abandoned |
NOREL, S.A. 1995-08-29 |
 BIOMET 73585352 1411822 Live/Registered |
BIOMET, INC. 1986-02-28 |
 BIOMET 73165517 1153792 Live/Registered |
BIOMET, INC. 1978-04-07 |
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