Biedermann Motech Universal Spinal System
FDA 510(k) K894184 · Biedermann Motech GmbH
510(k) numberK894184
Submission
- Device name
- Biedermann Motech Universal Spinal System
- Applicant
- Biedermann Motech GmbH
Vs-Schwenningen, DE - Received
- June 16, 1989
- Decision date
- April 25, 1990
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- JDN – Implant, Fixation Device, Spinal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JDN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K954856 | Cannulated Femoral NailJDN · Traditional | Synthes (Usa) | 03/08/1996SE |
| K897141 | Slot Staples and Adaptor for Zielke Spinal FixatioJDN · Traditional | Stuart | 06/21/1990SN |
| K873977 | New C-D System for Spinal SurgeryJDN · Traditional | Sofamor Co. | 12/07/1987SN |
| K872715 | Universal Instrumentation(Cd) for Spinal SurgeryJDN · Traditional | Roseburg SA | 12/07/1987SN |
| K760649 | Total Spinal CorrectionJDN · Traditional | Depuy, Inc. | 10/05/1976SE |
More from Depuy, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K203607 | MOSS VRS Spinal SystemNKB · Traditional | 08/20/2021SE |
| K181821 | MOSS VRS Spinal SystemNKB · Traditional | 09/13/2018SE |
| K170890 | TELIX K Interbody SystemMAX · Traditional | 06/02/2017SE |
| K162232 | MOSS 100 Pedicle Screw SystemNKB · Traditional | 11/17/2016SE |
| K900138 | Motech Titanium Surgical MeshEZX · Traditional | 03/20/1990SE |
Questions and answers
When was Biedermann Motech Universal Spinal System cleared by the FDA?
Biedermann Motech Universal Spinal System (K894184) received a 510(k) decision of Substantially Equivalent for Some Indications on April 25, 1990, 313 days after the submission was received.
What is the product code of K894184?
The FDA product code is JDN – Implant, Fixation Device, Spinal, a Class II (moderate risk) device regulated under 21 CFR 888.3060.