The following data is part of a premarket notification filed by Acromed Corp. with the FDA for Kaneda Anterior Scoliosis System Kass.
Device ID | K974757 |
510k Number | K974757 |
Device Name: | KANEDA ANTERIOR SCOLIOSIS SYSTEM KASS |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | ACROMED CORP. 3303 CARNEGIE AVE. Cleveland, OH 44115 |
Contact | Greg Cannedy |
Correspondent | Greg Cannedy ACROMED CORP. 3303 CARNEGIE AVE. Cleveland, OH 44115 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-12-19 |
Decision Date | 1998-03-05 |
Summary: | summary |