The following data is part of a premarket notification filed by 4-web, Inc. with the FDA for 4web Osteotomy Bone Wedge.
| Device ID | K130185 |
| 510k Number | K130185 |
| Device Name: | 4WEB OSTEOTOMY BONE WEDGE |
| Classification | Plate, Fixation, Bone |
| Applicant | 4-WEB, INC. 13540 GUILD AVE. Apple Valley, MN 55124 |
| Contact | Rich Jansen, Pharm, D. |
| Correspondent | Rich Jansen, Pharm, D. 4-WEB, INC. 13540 GUILD AVE. Apple Valley, MN 55124 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-25 |
| Decision Date | 2013-06-07 |
| Summary: | summary |