The following data is part of a premarket notification filed by Metasurg with the FDA for Metasurg Cannulated Tiatanium Hemi Implant, Model Hm-1000.
| Device ID | K083469 |
| 510k Number | K083469 |
| Device Name: | METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000 |
| Classification | Prosthesis, Toe, Hemi-, Phalangeal |
| Applicant | METASURG 16350 PARK TEN PL., SUITE 101 Houston, TX 77084 |
| Contact | Mark Myers |
| Correspondent | Mark Myers METASURG 16350 PARK TEN PL., SUITE 101 Houston, TX 77084 |
| Product Code | KWD |
| CFR Regulation Number | 888.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-24 |
| Decision Date | 2009-02-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780116394 | K083469 | 000 |
| 00885556821695 | K083469 | 000 |
| 00885556821701 | K083469 | 000 |
| 00885556821718 | K083469 | 000 |
| 00885556821725 | K083469 | 000 |
| M268BIOMOTIONIMP1 | K083469 | 000 |
| 10381780116356 | K083469 | 000 |
| 10381780116363 | K083469 | 000 |
| 10381780116370 | K083469 | 000 |
| 10381780116387 | K083469 | 000 |
| 00885556821688 | K083469 | 000 |