The following data is part of a premarket notification filed by Storz Am Mark Gmbh with the FDA for Stoma Bone Screw.
| Device ID | K051871 |
| 510k Number | K051871 |
| Device Name: | STOMA BONE SCREW |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | STORZ AM MARK GMBH GRIESWEG 47 Muehlheim, DE 78570 |
| Contact | Franz Menean |
| Correspondent | Franz Menean STORZ AM MARK GMBH GRIESWEG 47 Muehlheim, DE 78570 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-11 |
| Decision Date | 2005-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| ESAM23053101 | K051871 | 000 |
| ESAM23051081 | K051871 | 000 |
| ESAM23051101 | K051871 | 000 |
| ESAM23051121 | K051871 | 000 |
| ESAM23051141 | K051871 | 000 |
| ESAM23051161 | K051871 | 000 |
| ESAM23052081 | K051871 | 000 |
| ESAM23052101 | K051871 | 000 |
| ESAM23052121 | K051871 | 000 |
| ESAM23052141 | K051871 | 000 |
| ESAM23052161 | K051871 | 000 |
| ESAM23053041 | K051871 | 000 |
| ESAM23053061 | K051871 | 000 |
| ESAM23053081 | K051871 | 000 |
| ESAM23051061 | K051871 | 000 |