Alumina 6565-0-032
GUDID 04546540402134
Alumina Ceramic V40 Femoral Head
Howmedica Osteonics Corp.
Ceramic femoral head prosthesis| Primary Device ID | 04546540402134 |
| NIH Device Record Key | e5113789-a21b-4923-8efa-e6e23dcf8a8f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Alumina |
| Version Model Number | 6565-0-032 |
| Catalog Number | 6565-0-032 |
| Company DUNS | 058311945 |
| Company Name | Howmedica Osteonics Corp. |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Device Size Text, specify | 0 |
| Outer Diameter | 32 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 32 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 32 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 32 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 32 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 32 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 32 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 32 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 32 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 32 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 32 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 32 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 32 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 32 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 32 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 32 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 32 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 32 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 32 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 32 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 32 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 32 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 32 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 32 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 32 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 32 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 32 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 32 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04546540402134 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K023901
FDA Product Code
| LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented |
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 | 2015-09-24 |
On-Brand Devices [Alumina]
| 07613327101270 | Alumina Ceramic C-Taper Femoral Head |
| 07613327101249 | Alumina Ceramic C-Taper Femoral Head |
| 07613327101201 | Alumina Ceramic C-Taper Femoral Head |
| 07613327101188 | Alumina Ceramic C-Taper Femoral Head |
| 07613327101171 | Alumina Ceramic C-Taper Femoral Head |
| 07613327101164 | Alumina Ceramic C-Taper Femoral Head |
| 04546540402141 | Alumina Ceramic V40 Femoral Head |
| 04546540402134 | Alumina Ceramic V40 Femoral Head |
| 04546540402127 | Alumina Ceramic V40 Femoral Head |
| 04546540390516 | Alumina Ceramic V40 Femoral Head |
| 04546540390509 | Alumina Ceramic V40 Femoral Head |
| 04546540390493 | Alumina Ceramic V40 Femoral Head |
| 04546540390486 | Alumina Ceramic V40 Femoral Head |
| 04546540390479 | Alumina Ceramic V40 Femoral Head |
| 04546540390462 | Alumina Ceramic V40 Femoral Head |
| 04546540195647 | Alumina Ceramic C-Taper Femoral Head |
| 04546540195616 | Ceramic C-Taper Femoral Head |
| 04546540195586 | Ceramic C-Taper Femoral Head |
Trademark Results [Alumina]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ALUMINA 90678411 not registered Live/Pending |
TRES ALEGRIAS, S.A. DE C.V. 2021-04-28 |
 ALUMINA 90676352 not registered Live/Pending |
TRES ALEGRIAS, S.A. DE C.V. 2021-04-28 |
 ALUMINA 85763308 4489344 Live/Registered |
Lamplight Farms Incorporated 2012-10-25 |
 ALUMINA 85711714 not registered Dead/Abandoned |
Michael Beaumont 2012-08-23 |
 ALUMINA 78416134 2988295 Live/Registered |
Leupold & Stevens, Inc. 2004-05-10 |
 ALUMINA 78258469 2912789 Dead/Cancelled |
Alumina Limited 2003-06-04 |
 ALUMINA 78032258 not registered Dead/Abandoned |
Conair Corporation 2000-10-25 |
 ALUMINA 77683557 3883556 Dead/Cancelled |
Tantus, Inc. 2009-03-04 |
 ALUMINA 77583955 not registered Dead/Abandoned |
Thor Tech, Inc. 2008-10-02 |
 ALUMINA 77490147 3645978 Dead/Cancelled |
3Gen, LLC. 2008-06-03 |
 ALUMINA 75708429 2326748 Live/Registered |
KOLCRAFT ENTERPRISES, INC. 1999-05-18 |
 ALUMINA 75591909 2318657 Dead/Cancelled |
HUFFY CORPORATION 1998-11-19 |
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