The following data is part of a premarket notification filed by Mcconnell Orthopedic with the FDA for Mcconnell Orthopedic Tibial Positioner.
Device ID | K871823 |
510k Number | K871823 |
Device Name: | MCCONNELL ORTHOPEDIC TIBIAL POSITIONER |
Classification | Operating Room Accessories Table Tray |
Applicant | MCCONNELL ORTHOPEDIC TREEE LINCOLN CENTRE 5430 LBJ FREEWAY SUITE 1540 Dallas, TX 75240 |
Contact | Dennis T Griggs |
Correspondent | Dennis T Griggs MCCONNELL ORTHOPEDIC TREEE LINCOLN CENTRE 5430 LBJ FREEWAY SUITE 1540 Dallas, TX 75240 |
Product Code | FWZ |
CFR Regulation Number | 878.4950 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-11 |
Decision Date | 1987-05-26 |