MOTECH TITANIUM SURGICAL MESH
FDA 510(k) clearance K900138 · decided 1990-03-20
Clearance details
- K-number
- K900138
- Device name
- MOTECH TITANIUM SURGICAL MESH
- Applicant
- Biedermann Motech GmbH
- Decision
- Substantially Equivalent
- Date received
- 1990-01-11
- Decision date
- 1990-03-20
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- EZX
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Olney, MD, US
- Third-party review
- No
- Expedited review
- No
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| NUVASIVE MESH (K020853) | Nuvasive, Inc. | 2002-06-13 |
| SYNTHES SYNMESH (K983766) | Synthes (Usa) | 1998-12-18 |
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| TITANIUM MESH MAXILLOFACIAL IMPLANT SYSTEM (K896369) | Techmedica, Inc. | 1989-11-24 |
| STUART TITANIUM SURGICAL MESH (K890601) | Stuart | 1989-03-16 |
Recalls involving this device
No recalls on record reference this clearance.