The following data is part of a premarket notification filed by Precifit Medical Ltd with the FDA for Lumfuse-tp.
| Device ID | K171630 |
| 510k Number | K171630 |
| Device Name: | LumFuse-TP |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Precifit Medical Ltd 951 Aviation Pkwy Ste 100 Morrisville, NC 27560 |
| Contact | Zhenyu (eric) Wu |
| Correspondent | Kellen Hills Orchid Design 4600 E Shelby Dr Memphis, TN 38118 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-02 |
| Decision Date | 2017-07-25 |