The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Salvation Osteopenic Screw.
Device ID | K140408 |
510k Number | K140408 |
Device Name: | SALVATION OSTEOPENIC SCREW |
Classification | Screw, Fixation, Bone |
Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 1023 CHERRY ROAD Memphis, TN 38117 |
Contact | Val Myles |
Correspondent | Val Myles WRIGHT MEDICAL TECHNOLOGY, INC. 1023 CHERRY ROAD Memphis, TN 38117 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-02-18 |
Decision Date | 2014-05-14 |
Summary: | summary |