The following data is part of a premarket notification filed by Instratek, Inc. with the FDA for Stapix Superelastic Implant Bone Staples.
| Device ID | K133523 |
| 510k Number | K133523 |
| Device Name: | STAPIX SUPERELASTIC IMPLANT BONE STAPLES |
| Classification | Staple, Fixation, Bone |
| Applicant | INSTRATEK, INC. 15200 Middlebrook Dr Ste G Houston, TX 77058 |
| Contact | Jeff Seavey |
| Correspondent | Jeff Seavey INSTRATEK, INC. 15200 Middlebrook Dr Ste G Houston, TX 77058 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-15 |
| Decision Date | 2014-02-06 |
| Summary: | summary |