The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Biofoam Bone Wedge.
| Device ID | K142724 |
| 510k Number | K142724 |
| Device Name: | BIOFOAM Bone Wedge |
| Classification | Plate, Fixation, Bone |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 1023 Cherry Road Memphis, TN 38111 |
| 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 | 2014-09-23 |
| Decision Date | 2015-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420172051 | K142724 | 000 |
| 00840420171931 | K142724 | 000 |
| 00840420171924 | K142724 | 000 |
| 00840420171917 | K142724 | 000 |
| 00840420171900 | K142724 | 000 |
| 00840420171894 | K142724 | 000 |
| 00840420171887 | K142724 | 000 |
| 00840420171870 | K142724 | 000 |
| 00840420171863 | K142724 | 000 |
| 00840420171948 | K142724 | 000 |
| 00840420171955 | K142724 | 000 |
| 00840420171962 | K142724 | 000 |
| 00840420172044 | K142724 | 000 |
| 00840420172037 | K142724 | 000 |
| 00840420172020 | K142724 | 000 |
| 00840420172013 | K142724 | 000 |
| 00840420172006 | K142724 | 000 |
| 00840420171993 | K142724 | 000 |
| 00840420171986 | K142724 | 000 |
| 00840420171979 | K142724 | 000 |
| 00840420171856 | K142724 | 000 |