The following data is part of a premarket notification filed by Stuart Drug & Surgical Supply, Inc. with the FDA for Spinal Surgery Instrumentation.
Device ID | K782061 |
510k Number | K782061 |
Device Name: | SPINAL SURGERY INSTRUMENTATION |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | STUART DRUG & SURGICAL SUPPLY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-12-11 |
Decision Date | 1979-03-21 |