ASPIRON™ S ACP SYSTEM
GUDID 08800037503695
U&I CORPORATION
Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system| Primary Device ID | 08800037503695 |
| NIH Device Record Key | 737df674-86e5-4125-95a6-f8b52b47eeed |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ASPIRON™ S ACP SYSTEM |
| Version Model Number | FCA1039 |
| Company DUNS | 688811082 |
| Company Name | U&I CORPORATION |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800037503695 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K190053
FDA Product Code
| KWQ | Appliance, fixation, spinal intervertebral body |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800037503695]
Moist Heat or Steam Sterilization
[08800037503695]
Moist Heat or Steam Sterilization
[08800037503695]
Moist Heat or Steam Sterilization
[08800037503695]
Moist Heat or Steam Sterilization
[08800037503695]
Moist Heat or Steam Sterilization
[08800037503695]
Moist Heat or Steam Sterilization
[08800037503695]
Moist Heat or Steam Sterilization
[08800037503695]
Moist Heat or Steam Sterilization
[08800037503695]
Moist Heat or Steam Sterilization
[08800037503695]
Moist Heat or Steam Sterilization
[08800037503695]
Moist Heat or Steam Sterilization
[08800037503695]
Moist Heat or Steam Sterilization
[08800037503695]
Moist Heat or Steam Sterilization
[08800037503695]
Moist Heat or Steam Sterilization
[08800037503695]
Moist Heat or Steam Sterilization
[08800037503695]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-06-17 |
| Device Publish Date | 2019-06-07 |
On-Brand Devices [ASPIRON™ S ACP SYSTEM]
Trademark Results [ASPIRON]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ASPIRON 97092002 not registered Live/Pending |
Starfire Electronic Technology S.r.l 2021-10-25 |
 ASPIRON 97091999 not registered Live/Pending |
Starfire Electronic Technology S.r.l 2021-10-25 |
 ASPIRON 90828724 not registered Live/Pending |
SEE PROSPECT LIMITED 2021-07-14 |
 ASPIRON 90828709 not registered Live/Pending |
SEE PROSPECT LIMITED 2021-07-14 |
 ASPIRON 86907577 5092902 Live/Registered |
Cura Global Health, Inc 2016-02-15 |
 ASPIRON 86713720 not registered Dead/Abandoned |
Meril Life Sciences Private Limited 2015-08-04 |
 ASPIRON 78489650 not registered Dead/Abandoned |
Aspiron, Inc. 2004-09-26 |
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