The following data is part of a premarket notification filed by Mtp Solutions Llc with the FDA for Threaded Peek K-wire.
| Device ID | K133235 |
| 510k Number | K133235 |
| Device Name: | THREADED PEEK K-WIRE |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | MTP SOLUTIONS LLC 124 SOUTH 600 WEST, SUITE 100 Logan, UT 84321 |
| Contact | Robert Hoy |
| Correspondent | Robert Hoy MTP SOLUTIONS LLC 124 SOUTH 600 WEST, SUITE 100 Logan, UT 84321 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-21 |
| Decision Date | 2014-04-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885554034899 | K133235 | 000 |