The following data is part of a premarket notification filed by Biedermann Motech Gmbh with the FDA for Motech Titanium Surgical Mesh.
| Device ID | K900138 | 
| 510k Number | K900138 | 
| Device Name: | MOTECH TITANIUM SURGICAL MESH | 
| Classification | Mesh, Surgical, Metal | 
| Applicant | BIEDERMANN MOTECH GMBH 18159 VILLAGE MART DR. SUITE 243 Olney, MD 20832 | 
| Contact | Arthur B Mcintyre | 
| Correspondent | Arthur B Mcintyre BIEDERMANN MOTECH GMBH 18159 VILLAGE MART DR. SUITE 243 Olney, MD 20832  | 
| Product Code | EZX | 
| CFR Regulation Number | 878.3300 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1990-01-11 | 
| Decision Date | 1990-03-20 |