The following data is part of a premarket notification filed by Ht Medical, Llc with the FDA for Neofuse Ha Enhanced Plif/tlif.
| Device ID | K170511 |
| 510k Number | K170511 |
| Device Name: | NeoFuse HA Enhanced PLIF/TLIF |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | HT Medical, LLC 6316 E 102nd Street Tulsa, OK 74137 |
| Contact | Robert Compton |
| Correspondent | Allison Komiyama AcKnowledge Regulatory Strategies, LLC 2834 Hawthorn Street San Diego, CA 92104 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-21 |
| Decision Date | 2017-04-25 |
| Summary: | summary |