The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Pyramesh™ Implant System.
Device ID | K183197 |
510k Number | K183197 |
Device Name: | PYRAMESH™ Implant System |
Classification | Spinal Vertebral Body Replacement Device |
Applicant | Medtronic Sofamor Danek USA, INC. 1800 Pyramid Pl. Memphis, TN 38132 |
Contact | Ankit K. Shah |
Correspondent | Ankit K. Shah Medtronic Sofamor Danek USA, INC. 1800 Pyramid Pl. Memphis, TN 38132 |
Product Code | MQP |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-11-19 |
Decision Date | 2019-04-04 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PYRAMESH 75334348 2242033 Live/Registered |
WARSAW ORTHOPEDIC, INC. 1997-08-01 |