The following data is part of a premarket notification filed by Stuart with the FDA for Slot Staples And Adaptor For Zielke Spinal Fixatio.
| Device ID | K897141 |
| 510k Number | K897141 |
| Device Name: | SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO |
| Classification | Implant, Fixation Device, Spinal |
| Applicant | STUART ONE STUART PLAZA DONOHUE/LUXOR ROADS Greensburg, PA 15601 |
| Contact | Abraham Glasser |
| Correspondent | Abraham Glasser STUART ONE STUART PLAZA DONOHUE/LUXOR ROADS Greensburg, PA 15601 |
| Product Code | JDN |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-27 |
| Decision Date | 1990-06-21 |