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 | K153615 |
| 510k Number | K153615 |
| 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 | Nicholas Cordaro ADDITIVE INNOVATIONS, LLC 533 2ND ST. SUITE A Encinitas, CA 92024 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-17 |
| Decision Date | 2016-05-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818345020566 | K153615 | 000 |