The following data is part of a premarket notification filed by Acromed Corp. with the FDA for Kaneda Anterior Spinal Multisegmental Fixation Dev.
Device ID | K923703 |
510k Number | K923703 |
Device Name: | KANEDA ANTERIOR SPINAL MULTISEGMENTAL FIXATION DEV |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | ACROMED CORP. 3303 CARNEGIE AVE. Cleveland, OH 44115 |
Contact | Gregory D Cannedy |
Correspondent | Gregory D 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 | 1992-07-24 |
Decision Date | 1993-05-20 |