The following data is part of a premarket notification filed by Mednext, Inc. with the FDA for Mednext 1000 Bone Dissecting System.
| Device ID | K926547 |
| 510k Number | K926547 |
| Device Name: | MEDNEXT 1000 BONE DISSECTING SYSTEM |
| Classification | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment |
| Applicant | MEDNEXT, INC. 3878 PROSPECT AVENUE, SUITE 24 West Point Beach, FL 33404 |
| Contact | Thomas J Mickel |
| Correspondent | Thomas J Mickel MEDNEXT, INC. 3878 PROSPECT AVENUE, SUITE 24 West Point Beach, FL 33404 |
| Product Code | HSZ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-31 |
| Decision Date | 1993-07-22 |