The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Biofoam Bone Wedge.
| Device ID | K073535 |
| 510k Number | K073535 |
| Device Name: | BIOFOAM BONE WEDGE |
| Classification | Plate, Fixation, Bone |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Brad Sheals |
| Correspondent | Brad Sheals 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 | 2007-12-17 |
| Decision Date | 2008-01-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420135674 | K073535 | 000 |
| 00840420135667 | K073535 | 000 |
| 00840420135650 | K073535 | 000 |
| 00840420135643 | K073535 | 000 |