K894184 is an FDA 510(k) clearance for the BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM. This device is classified as a Implant, Fixation Device, Spinal (Class II - Special Controls, product code JDN).
Submitted by Biedermann Motech GmbH (Vs-Schwenningen, DE). The FDA issued a Cleared decision on April 25, 1990, 313 days after receiving the submission on June 16, 1989.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060.
| 510(k) Number | K894184 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | June 16, 1989 |
| Decision Date | April 25, 1990 |
| Days to Decision | 313 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | JDN — Implant, Fixation Device, Spinal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3060 |