The following data is part of a premarket notification filed by Storz Am Mark Gmbh with the FDA for Stoma Bone Block Screw.
| Device ID | K080430 |
| 510k Number | K080430 |
| Device Name: | STOMA BONE BLOCK SCREW |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | STORZ AM MARK GMBH EMMINGER STR. 39 Emmingen-liptingen, DE 78576 |
| Contact | Franz Menean |
| Correspondent | Franz Menean STORZ AM MARK GMBH EMMINGER STR. 39 Emmingen-liptingen, DE 78576 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-19 |
| Decision Date | 2008-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| ESAM23061161 | K080430 | 000 |
| ESAM23060081 | K080430 | 000 |
| ESAM23060061 | K080430 | 000 |
| ESAM23060041 | K080430 | 000 |
| ESAM23061130 | K080430 | 000 |
| ESAM23061110 | K080430 | 000 |
| ESAM23061090 | K080430 | 000 |
| ESAM23060130 | K080430 | 000 |
| ESAM23060110 | K080430 | 000 |
| ESAM23060101 | K080430 | 000 |
| ESAM23060121 | K080430 | 000 |
| ESAM23061141 | K080430 | 000 |
| ESAM23061121 | K080430 | 000 |
| ESAM23061101 | K080430 | 000 |
| ESAM23061081 | K080430 | 000 |
| ESAM23061061 | K080430 | 000 |
| ESAM23061041 | K080430 | 000 |
| ESAM23060161 | K080430 | 000 |
| ESAM23060141 | K080430 | 000 |
| ESAM23060090 | K080430 | 000 |