The following data is part of a premarket notification filed by Metasurg with the FDA for Metasurg Nitinol Staple Implant.
| Device ID | K123926 |
| 510k Number | K123926 |
| Device Name: | METASURG NITINOL STAPLE IMPLANT |
| Classification | Staple, Fixation, Bone |
| Applicant | METASURG SUITE 100 Houston, TX 77084 |
| Contact | Joshua Scott |
| Correspondent | Joshua Scott METASURG SUITE 100 Houston, TX 77084 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-20 |
| Decision Date | 2013-05-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M268STAPLEIMP1 | K123926 | 000 |
| M268MS1010101 | K123926 | 000 |
| M268MS0808081 | K123926 | 000 |
| 00885556827710 | K123926 | 000 |
| 00885556827703 | K123926 | 000 |
| 00885556827697 | K123926 | 000 |
| 00885556827680 | K123926 | 000 |
| 00885556827673 | K123926 | 000 |
| 00885556827666 | K123926 | 000 |
| 00885556827659 | K123926 | 000 |
| 00885556827642 | K123926 | 000 |
| 00885556827635 | K123926 | 000 |
| 00885556827628 | K123926 | 000 |
| 00885556827611 | K123926 | 000 |
| 00885556827604 | K123926 | 000 |
| M268MS1015131 | K123926 | 000 |
| M268MS1017151 | K123926 | 000 |
| M268MS2522221 | K123926 | 000 |
| M268MS2520201 | K123926 | 000 |
| M268MS2020201 | K123926 | 000 |
| M268MS2015151 | K123926 | 000 |
| M268MS1819171 | K123926 | 000 |
| M268MS1817151 | K123926 | 000 |
| M268MS1814141 | K123926 | 000 |
| M268MS1812121 | K123926 | 000 |
| M268MS1515151 | K123926 | 000 |
| M268MS1512121 | K123926 | 000 |
| M268MS1219161 | K123926 | 000 |
| M268MS1217151 | K123926 | 000 |
| M268MS1215131 | K123926 | 000 |
| M268MS1210101 | K123926 | 000 |
| 00885556827574 | K123926 | 000 |