The following data is part of a premarket notification filed by Spintech, Inc. with the FDA for Leaplaza Frame.
| Device ID | K922238 |
| 510k Number | K922238 |
| Device Name: | LEAPLAZA FRAME |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | SPINTECH, INC. 982 E. HENNEPIN AVE. Minneapolis, MN 55414 |
| Contact | Richard D Jensen |
| Correspondent | Richard D Jensen SPINTECH, INC. 982 E. HENNEPIN AVE. Minneapolis, MN 55414 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-13 |
| Decision Date | 1992-12-23 |