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 |