The following data is part of a premarket notification filed by U&i Corp. with the FDA for Perfix Spinal System, Model Sna4530-9610, Snm4530-9610, Sn3020 (total: 549).
Device ID | K091725 |
510k Number | K091725 |
Device Name: | PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549) |
Classification | Orthosis, Spondylolisthesis Spinal Fixation |
Applicant | U&I CORP. 529-1 YONGHYUN-DONG Euijungbu, Kyunggi-do, KR 480-050 |
Contact | Sung Youn Cho |
Correspondent | Sung Youn Cho U&I CORP. 529-1 YONGHYUN-DONG Euijungbu, Kyunggi-do, KR 480-050 |
Product Code | MNH |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-06-11 |
Decision Date | 2009-11-09 |
Summary: | summary |