The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Evolve Eps Ortholoc.
Device ID | K100146 |
510k Number | K100146 |
Device Name: | EVOLVE EPS ORTHOLOC |
Classification | Plate, Fixation, Bone |
Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
Contact | Kelsey Lee |
Correspondent | Kelsey Lee WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-01-19 |
Decision Date | 2010-02-02 |
Summary: | summary |