The following data is part of a premarket notification filed by U & I Corporation with the FDA for Anax 5.5 Spinal System.
Device ID | K132101 |
510k Number | K132101 |
Device Name: | ANAX 5.5 SPINAL SYSTEM |
Classification | Orthosis, Spondylolisthesis Spinal Fixation |
Applicant | U & I CORPORATION 20, SANDAN-RO, 76BEON-GIL (RD) Uijeongbu-si, Gyeonggi-do, KR 480-859 |
Contact | Young-geun Kim |
Correspondent | Young-geun Kim U & I CORPORATION 20, SANDAN-RO, 76BEON-GIL (RD) Uijeongbu-si, Gyeonggi-do, KR 480-859 |
Product Code | MNH |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-07-08 |
Decision Date | 2013-11-25 |
Summary: | summary |