The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Sidekick Circular Fixator System: Struts And Hinges.
| Device ID | K100137 |
| 510k Number | K100137 |
| Device Name: | SIDEKICK CIRCULAR FIXATOR SYSTEM: STRUTS AND HINGES |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Megan Mccagh |
| Correspondent | Megan Mccagh WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | KTT |
| 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 | 2010-06-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420128737 | K100137 | 000 |
| 00840420128720 | K100137 | 000 |
| 00840420128713 | K100137 | 000 |
| 00889797102926 | K100137 | 000 |