Motech Titanium Surgical Mesh
FDA 510(k) K900138 · Biedermann Motech GmbH
510(k) numberK900138
Submission
- Device name
- Motech Titanium Surgical Mesh
- Applicant
- Biedermann Motech GmbH
Olney, MD, US - Received
- January 11, 1990
- Decision date
- March 20, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EZX – Mesh, Surgical, Metal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code EZX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K063461 | Anova Containment DeviceEZX · Traditional | Anova Corporation | 08/13/2009SE |
| K014200 | OptimeshEZX · Traditional | Spineology, Inc. | 11/26/2003SESU |
| K032344 | The Hedrocel Trabecular Metal Reconstruction System Model 10-330EZX · Special | Implex Corp. | 10/02/2003SE |
| K032282 | Modification to Hedrocel Trabecular Metal Reconstruction SystemEZX · Special | Implex Corp. | 08/21/2003SE |
| K024169 | Macropore Os ReconstructionEZX · Traditional | Macropore Biosurgery, Inc. | 07/01/2003SE |
| K023882 | The Hedrocel Trabecular Metal Reconstruction SystemEZX · Traditional | Implex Corp. | 02/19/2003SE |
| K020853 | Nuvasive MeshEZX · Traditional | Nuvasive, Inc. | 06/13/2002SE |
| K983766 | Synthes SynmeshEZX · Traditional | Synthes (Usa) | 12/18/1998SE |
| K945027 | Trochanter MeshEZX · Traditional | Acu Med, Inc. | 02/01/1995SN |
| K896369 | Titanium Mesh Maxillofacial Implant SystemEZX · Traditional | Techmedica, Inc. | 11/24/1989SE |
More from Techmedica, 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 |
| K894184 | Biedermann Motech Universal Spinal SystemJDN · Traditional | 04/25/1990SN |
Questions and answers
When was Motech Titanium Surgical Mesh cleared by the FDA?
Motech Titanium Surgical Mesh (K900138) received a 510(k) decision of Substantially Equivalent on March 20, 1990, 68 days after the submission was received.
What is the product code of K900138?
The FDA product code is EZX – Mesh, Surgical, Metal, a Class II (moderate risk) device regulated under 21 CFR 878.3300.