Alteon SPI-038513
GUDID 10885862595980
ALTEON HA BROACH W/ VERSION HOLE SZ 3
Exactech, Inc.
Orthopaedic broach| Primary Device ID | 10885862595980 |
| NIH Device Record Key | fe1e88b2-ecb9-4906-b0cb-2cc70c23e19b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Alteon |
| Version Model Number | SPI-038513 |
| Catalog Number | SPI-038513 |
| Company DUNS | 157565946 |
| Company Name | Exactech, Inc. |
| 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 | false |
| 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 |
| 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 | 10885862595980 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K162732
FDA Product Code
| MEH | Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10885862595980]
Moist Heat or Steam Sterilization
[10885862595980]
Moist Heat or Steam Sterilization
[10885862595980]
Moist Heat or Steam Sterilization
[10885862595980]
Moist Heat or Steam Sterilization
[10885862595980]
Moist Heat or Steam Sterilization
[10885862595980]
Moist Heat or Steam Sterilization
[10885862595980]
Moist Heat or Steam Sterilization
[10885862595980]
Moist Heat or Steam Sterilization
[10885862595980]
Moist Heat or Steam Sterilization
[10885862595980]
Moist Heat or Steam Sterilization
[10885862595980]
Moist Heat or Steam Sterilization
[10885862595980]
Moist Heat or Steam Sterilization
[10885862595980]
Moist Heat or Steam Sterilization
[10885862595980]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-26 |
| Device Publish Date | 2022-08-18 |
On-Brand Devices [Alteon]
Trademark Results [Alteon]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ALTEON 90979106 not registered Live/Pending |
Third Summit Corporation 2020-06-14 |
 ALTEON 90000724 not registered Live/Pending |
Third Summit Corporation 2020-06-14 |
 ALTEON 90000722 not registered Live/Pending |
Third Summit Corporation 2020-06-14 |
 ALTEON 90000721 not registered Live/Pending |
Third Summit Corporation 2020-06-14 |
 ALTEON 88141070 5739838 Live/Registered |
Turn 5, Inc. 2018-10-03 |
 ALTEON 86260493 4664902 Live/Registered |
Exactech, Inc. 2014-04-23 |
 ALTEON 79154859 not registered Dead/Abandoned |
AQUASOURCE 2014-09-03 |
 ALTEON 79033548 3385726 Dead/Cancelled |
AQUASOURCE 2006-12-01 |
 ALTEON 78207064 2944908 Dead/Cancelled |
Boeing Management Company 2003-01-24 |
 ALTEON 78207063 3077319 Dead/Cancelled |
Boeing Management Company 2003-01-24 |
 ALTEON 78207061 not registered Dead/Abandoned |
Boeing Management Company 2003-01-24 |
 ALTEON 76628875 3122426 Dead/Cancelled |
Alteon Inc. 2005-01-24 |
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