The following data is part of a premarket notification filed by Mtp Solutions Llc with the FDA for One-piece Peek Fusion Implant.
| Device ID | K140970 |
| 510k Number | K140970 |
| Device Name: | ONE-PIECE PEEK FUSION IMPLANT |
| Classification | Screw, Fixation, Bone |
| 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-16 |
| Decision Date | 2014-05-13 |
| Summary: | summary |