The following data is part of a premarket notification filed by Mtp Solutions Llc with the FDA for Peek Fusion Implant.
| Device ID | K133515 |
| 510k Number | K133515 |
| Device Name: | 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-15 |
| Decision Date | 2014-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885554036039 | K133515 | 000 |
| 00885554034912 | K133515 | 000 |
| 00885554034929 | K133515 | 000 |
| 00885554034936 | K133515 | 000 |
| 00885554034943 | K133515 | 000 |
| 00885554034950 | K133515 | 000 |
| 00885554034967 | K133515 | 000 |
| 00885554034974 | K133515 | 000 |
| 00885554036008 | K133515 | 000 |
| 00885554036015 | K133515 | 000 |
| 00885554036022 | K133515 | 000 |
| 00885554034905 | K133515 | 000 |