The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Total Spinal Correction.
Device ID | K760649 |
510k Number | K760649 |
Device Name: | TOTAL SPINAL CORRECTION |
Classification | Implant, Fixation Device, Spinal |
Applicant | DEPUY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JDN |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-09-15 |
Decision Date | 1976-10-05 |