The following data is part of a premarket notification filed by Spinal Concepts, Inc. with the FDA for Bacfix Spinal Fixation System.
Device ID | K964404 |
510k Number | K964404 |
Device Name: | BACFIX SPINAL FIXATION SYSTEM |
Classification | Appliance, Fixation, Spinal Interlaminal |
Applicant | SPINAL CONCEPTS, INC. 701 BRAZOS SUITE 500 Austin, TX 78701 |
Contact | Erin Mcgurk |
Correspondent | Erin Mcgurk SPINAL CONCEPTS, INC. 701 BRAZOS SUITE 500 Austin, TX 78701 |
Product Code | KWP |
CFR Regulation Number | 888.3050 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-11-04 |
Decision Date | 1997-03-26 |