The following data is part of a premarket notification filed by Blackstone Medical, Inc. with the FDA for Blackstone Spinal Fixation System.
Device ID | K994217 |
510k Number | K994217 |
Device Name: | BLACKSTONE SPINAL FIXATION SYSTEM |
Classification | Orthosis, Spondylolisthesis Spinal Fixation |
Applicant | BLACKSTONE MEDICAL, INC. 90 BROOKSDALE DR. Springfield, MA 01104 |
Contact | Alan Lombardo |
Correspondent | Alan Lombardo BLACKSTONE MEDICAL, INC. 90 BROOKSDALE DR. Springfield, MA 01104 |
Product Code | MNH |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-12-15 |
Decision Date | 2000-02-28 |
Summary: | summary |