The following data is part of a premarket notification filed by Chin Bone Technique Corp with the FDA for Cb Prot Ii Posterior Spinal System.
Device ID | K142655 |
510k Number | K142655 |
Device Name: | CB PROT II Posterior Spinal System |
Classification | Orthosis, Spondylolisthesis Spinal Fixation |
Applicant | CHIN BONE TECHNIQUE CORP 1F., NO. 165, SEC, 2, XIAN ST., BEITOU DIST. Taipei, TW 11274 |
Contact | Cheng-kung Cheng |
Correspondent | Cheng-kung Cheng CHIN BONE TECHNIQUE CORP NO. 165, SEC, 2, XIAN ST., BEITOU DIST. Taipei, CN 11274 |
Product Code | MNH |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-09-18 |
Decision Date | 2015-01-26 |
Summary: | summary |