The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Ortholoc 2.0/2.4 Plate System.
Device ID | K090692 |
510k Number | K090692 |
Device Name: | ORTHOLOC 2.0/2.4 PLATE SYSTEM |
Classification | Plate, Fixation, Bone |
Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
Contact | Fred W Bowman |
Correspondent | Fred W Bowman WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-03-16 |
Decision Date | 2009-05-08 |
Summary: | summary |