The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Sidekick Ez Frame External Fixation System.
Device ID | K143220 |
510k Number | K143220 |
Device Name: | SIDEKICK EZ FRAME External Fixation System |
Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 1023 Cherry Road Memphis, TN 38117 |
Contact | Leslie Fitch |
Correspondent | Leslie Fitch WRIGHT MEDICAL TECHNOLOGY, INC. 1023 Cherry Road Memphis, TN 38117 |
Product Code | KTT |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-11-10 |
Decision Date | 2015-01-08 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00889797058599 | K143220 | 000 |
00889797103091 | K143220 | 000 |
00889797058315 | K143220 | 000 |
00889797058322 | K143220 | 000 |
00889797058360 | K143220 | 000 |
00889797058414 | K143220 | 000 |
00889797058469 | K143220 | 000 |
00889797058476 | K143220 | 000 |
00889797058506 | K143220 | 000 |
00889797058513 | K143220 | 000 |
00889797058544 | K143220 | 000 |
00889797058575 | K143220 | 000 |
00889797058582 | K143220 | 000 |
00889797066693 | K143220 | 000 |
00889797066709 | K143220 | 000 |
00889797066723 | K143220 | 000 |
00889797103053 | K143220 | 000 |