The following data is part of a premarket notification filed by Feet For Life Podiatry Center with the FDA for Easy Out.
| Device ID | K141401 |
| 510k Number | K141401 |
| Device Name: | EASY OUT |
| Classification | Screw, Fixation, Bone |
| Applicant | FEET FOR LIFE PODIATRY CENTER 8637 DELMAR BLVD. Saint Louis, MO 63124 |
| Contact | Michael Horwitz |
| Correspondent | Carrie Hetrick EMERGO GROUP 816 CONGRESS AVENUE, SUITE 1400 Austn, TX 78701 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-28 |
| Decision Date | 2015-02-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853785008040 | K141401 | 000 |
| 00853785008033 | K141401 | 000 |
| 00853785008026 | K141401 | 000 |
| 00853785008019 | K141401 | 000 |
| 00853785008002 | K141401 | 000 |