The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Cannulated Screw System.
Device ID | K143460 |
510k Number | K143460 |
Device Name: | Cannulated Screw System |
Classification | Screw, Fixation, Bone |
Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 1023 Cherry Road Memphis, TN 38117 |
Contact | Tara Conrad |
Correspondent | Tara Conrad 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 | 2014-12-04 |
Decision Date | 2015-01-23 |
Summary: | summary |