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 |