The following data is part of a premarket notification filed by Gbs Commonwealth Co., Ltd. with the FDA for Prase Peek Anterior Cervical Interbody Spacer.
Device ID | K202872 |
510k Number | K202872 |
Device Name: | Prase PEEK Anterior Cervical Interbody Spacer |
Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
Applicant | GBS Commonwealth Co., Ltd. C-309, Woolim Lion's Valley, 168, Gasan Digital 1-ro Geumcheon-gu, KR 08507 |
Contact | Jimmy Kim |
Correspondent | Jimmy Kim GBS Commonwealth Co., Ltd. C-309, Woolim Lion's Valley, 168, Gasan Digital 1-ro Geumcheon-gu, KR 08507 |
Product Code | ODP |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-09-28 |
Decision Date | 2021-02-04 |