The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Ortholoc 3di Midfoot/flatfoot System.
| Device ID | K121651 |
| 510k Number | K121651 |
| Device Name: | ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Leslie Fitch |
| Correspondent | Leslie Fitch 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 | 2012-06-05 |
| Decision Date | 2012-10-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420123343 | K121651 | 000 |
| 00840420156129 | K121651 | 000 |
| 00840420156112 | K121651 | 000 |
| 00840420156051 | K121651 | 000 |
| 00840420156044 | K121651 | 000 |
| 00840420156037 | K121651 | 000 |
| 00840420156020 | K121651 | 000 |
| 00840420156013 | K121651 | 000 |
| 00840420156006 | K121651 | 000 |
| 00840420155993 | K121651 | 000 |
| 00840420155986 | K121651 | 000 |
| 00840420126474 | K121651 | 000 |
| 00840420126467 | K121651 | 000 |
| 00840420126450 | K121651 | 000 |
| 00840420126443 | K121651 | 000 |
| 00840420126436 | K121651 | 000 |
| 00840420126429 | K121651 | 000 |
| 00840420126412 | K121651 | 000 |
| 00840420156136 | K121651 | 000 |
| 00840420156143 | K121651 | 000 |
| 00840420156150 | K121651 | 000 |
| 00840420123336 | K121651 | 000 |
| 00840420123329 | K121651 | 000 |
| 00840420123312 | K121651 | 000 |
| 00840420123305 | K121651 | 000 |
| 00840420123299 | K121651 | 000 |
| 00840420123282 | K121651 | 000 |
| 00840420123275 | K121651 | 000 |
| 00840420123268 | K121651 | 000 |
| 00840420123251 | K121651 | 000 |
| 00840420123244 | K121651 | 000 |
| 00840420123237 | K121651 | 000 |
| 00840420123220 | K121651 | 000 |
| 00840420123213 | K121651 | 000 |
| 00840420123206 | K121651 | 000 |
| 00840420156204 | K121651 | 000 |
| 00840420156198 | K121651 | 000 |
| 00840420156167 | K121651 | 000 |
| 00840420126405 | K121651 | 000 |