The following data is part of a premarket notification filed by Solco Biomedical Co., Ltd. with the FDA for 4cis Peek Plif Cage, 4cis Pebble Beach Peek Plif Cage, 4cis Torrey Pines Peek Tlif Cage, 4cis Dunes Peek Dlif Cage, 4cis Augusta Peek Alif Cage.
Device ID | K190563 |
510k Number | K190563 |
Device Name: | 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | Solco Biomedical Co., Ltd. 154 Seotan-ro, Seotan-myeon Pyeongtaek, KR 17704 |
Contact | Il Kim |
Correspondent | Hwi-geun Yu First Gold Corp. 154 Seotan-ro, Seotan-myeon, Pyeongtaek, Gyeonggi-do, 17704 Republic Of Korea Republic Of K KR |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-03-05 |
Decision Date | 2019-09-18 |
Summary: | summary |