The following data is part of a premarket notification filed by Innovasis, Inc. with the FDA for Px Peek Ibf System.
Device ID | K150500 |
510k Number | K150500 |
Device Name: | Px PEEK IBF System |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | INNOVASIS, INC. 614 EAST 3900 SOUTH Salt Lake City, UT 84107 |
Contact | Marshall Mccarty |
Correspondent | Marshall Mccarty INNOVASIS, INC. 614 EAST 3900 SOUTH Salt Lake City, UT 84107 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-02-26 |
Decision Date | 2015-06-19 |
Summary: | summary |