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 | K130044 |
| 510k Number | K130044 |
| Device Name: | SIDEKICK EZ FRAME EXTERNAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Ryan Bormann |
| Correspondent | Ryan Bormann WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | KTT |
| Subsequent Product Code | HTY |
| Subsequent Product Code | JEC |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-08 |
| Decision Date | 2013-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420128478 | K130044 | 000 |
| 00889797102964 | K130044 | 000 |
| 00889797102971 | K130044 | 000 |
| 00889797102995 | K130044 | 000 |
| 00889797103008 | K130044 | 000 |
| 00889797103039 | K130044 | 000 |
| 00889797103046 | K130044 | 000 |
| 00889797103060 | K130044 | 000 |
| 00889797103077 | K130044 | 000 |
| 00889797058490 | K130044 | 000 |
| 00840420128423 | K130044 | 000 |
| 00889797102780 | K130044 | 000 |