The following data is part of a premarket notification filed by Smith & Nephew, Inc with the FDA for Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based Software.
Device ID | K142520 |
510k Number | K142520 |
Device Name: | Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based Software |
Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
Applicant | Smith & Nephew, Inc 1450 Brooks Road Memphis, TN 38116 |
Contact | Martin Ostmann |
Correspondent | Martin Ostmann Smith & Nephew, Inc 1450 Brooks Road Memphis, TN 38116 |
Product Code | KTT |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-09-08 |
Decision Date | 2014-11-20 |
Summary: | summary |