The following data is part of a premarket notification filed by Summit Medventures with the FDA for Smv Scientific K-wire And Pins.
| Device ID | K182171 |
| 510k Number | K182171 |
| Device Name: | SMV Scientific K-Wire And Pins |
| Classification | Pin, Fixation, Threaded |
| Applicant | Summit MedVentures 7500 Rialto Blvd, Bldg 1, Ste 225 Austin, TX 78738 |
| Contact | Nephi Zufelt |
| Correspondent | Meredith May Empirical Consulting LLC 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-10 |
| Decision Date | 2018-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816950025334 | K182171 | 000 |
| 00816950025327 | K182171 | 000 |
| 00816950025310 | K182171 | 000 |
| 00816950025303 | K182171 | 000 |
| 00816950025297 | K182171 | 000 |