The following data is part of a premarket notification filed by Biedermann Motech Gmbh with the FDA for Biedermann Motech Universal Spinal System.
| Device ID | K894184 |
| 510k Number | K894184 |
| Device Name: | BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM |
| Classification | Implant, Fixation Device, Spinal |
| Applicant | BIEDERMANN MOTECH GMBH BERTA-SUTTNER-STRASSE 23 Vs-schwenningen, DE D-78054 |
| Contact | Lutz Biedermann |
| Correspondent | Lutz Biedermann BIEDERMANN MOTECH GMBH BERTA-SUTTNER-STRASSE 23 Vs-schwenningen, DE D-78054 |
| 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 | 1989-06-16 |
| Decision Date | 1990-04-25 |