DirectInject
Methyl Methacrylate For Cranioplasty
STRYKER
The following data is part of a premarket notification filed by Stryker with the FDA for Directinject.
Pre-market Notification Details
| Device ID | K143661 |
| 510k Number | K143661 |
| Device Name: | DirectInject |
| Classification | Methyl Methacrylate For Cranioplasty |
| Applicant | STRYKER 750 TRADE CENTRE WAY - SUITE 200 Portage, MI 49002 |
| Contact | Nathan Vansweden |
| Correspondent | Nathan Vansweden STRYKER 750 TRADE CENTRE WAY - SUITE 200 Portage, MI 49002 |
| Product Code | GXP |
| CFR Regulation Number | 882.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-23 |
| Decision Date | 2015-09-02 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327425475 | K143661 | 000 |
| 07613327425468 | K143661 | 000 |
| 07613327123371 | K143661 | 000 |
| 07613327123272 | K143661 | 000 |
| 07613327123265 | K143661 | 000 |
Trademark Results [DirectInject]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DIRECTINJECT 86517041 5306925 Live/Registered |
Stryker European Holdings I, LLC 2015-01-28 |
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