The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Ortholoc(r) 3di Ankle Plating System.
| Device ID | K131093 |
| 510k Number | K131093 |
| Device Name: | ORTHOLOC(R) 3DI ANKLE PLATING SYSTEM |
| Classification | Plate, Fixation, Bone |
| 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-18 |
| Decision Date | 2013-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420123589 | K131093 | 000 |
| 00840420152329 | K131093 | 000 |
| 00840420152336 | K131093 | 000 |
| 00840420152343 | K131093 | 000 |
| 00840420152350 | K131093 | 000 |
| 00840420152367 | K131093 | 000 |
| 00840420152374 | K131093 | 000 |
| 00840420152381 | K131093 | 000 |
| 00840420156174 | K131093 | 000 |
| 00840420156181 | K131093 | 000 |
| 00840420123510 | K131093 | 000 |
| 00840420123527 | K131093 | 000 |
| 00840420123534 | K131093 | 000 |
| 00840420123541 | K131093 | 000 |
| 00840420123558 | K131093 | 000 |
| 00840420123565 | K131093 | 000 |
| 00840420123572 | K131093 | 000 |
| 00840420152312 | K131093 | 000 |