The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Biofoam Bone Wedge.
| Device ID | K140531 |
| 510k Number | K140531 |
| Device Name: | BIOFOAM BONE WEDGE |
| Classification | Plate, Fixation, Bone |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 1023 CHERRY ROAD Memphis, TN 38117 |
| Contact | Val Myles |
| Correspondent | Val Myles WRIGHT MEDICAL TECHNOLOGY, INC. 1023 CHERRY ROAD Memphis, TN 38117 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-04 |
| Decision Date | 2014-07-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420165992 | K140531 | 000 |
| 00840420165985 | K140531 | 000 |
| 00840420163196 | K140531 | 000 |
| 00840420163189 | K140531 | 000 |
| 00840420163172 | K140531 | 000 |
| 00840420163165 | K140531 | 000 |
| 00840420163158 | K140531 | 000 |
| 00840420163141 | K140531 | 000 |