The following data is part of a premarket notification filed by Metasurg with the FDA for Metasurg Digifuse Implant.
| Device ID | K111536 |
| 510k Number | K111536 |
| Device Name: | METASURG DIGIFUSE IMPLANT |
| Classification | Screw, Fixation, Bone |
| Applicant | METASURG 16350 PARK TEN PL., SUITE 101 Houston, TX 77084 |
| Contact | Joshua Scott |
| Correspondent | Joshua Scott METASURG 16350 PARK TEN PL., SUITE 101 Houston, TX 77084 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-02 |
| Decision Date | 2011-07-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M268DIGIFUSEIMP21 | K111536 | 000 |
| 00885556824825 | K111536 | 000 |
| 00885556824818 | K111536 | 000 |
| 00885556824801 | K111536 | 000 |
| 00885556824795 | K111536 | 000 |
| 00885556824788 | K111536 | 000 |
| 00885556824771 | K111536 | 000 |
| 00885556824764 | K111536 | 000 |