Synthes Synmesh
FDA 510(k) K983766 · Synthes (Usa)
510(k) numberK983766
Submission
- Device name
- Synthes Synmesh
- Applicant
- Synthes (Usa)
Paoli, PA, US - Received
- October 26, 1998
- Decision date
- December 18, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| K945027 | Trochanter MeshEZX · Traditional | Acu Med, Inc. | 02/01/1995SN |
| K900138 | Motech Titanium Surgical MeshEZX · Traditional | Biedermann Motech GmbH | 03/20/1990SE |
| K896369 | Titanium Mesh Maxillofacial Implant SystemEZX · Traditional | Techmedica, Inc. | 11/24/1989SE |
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Questions and answers
When was Synthes Synmesh cleared by the FDA?
Synthes Synmesh (K983766) received a 510(k) decision of Substantially Equivalent on December 18, 1998, 53 days after the submission was received.
What is the product code of K983766?
The FDA product code is EZX – Mesh, Surgical, Metal, a Class II (moderate risk) device regulated under 21 CFR 878.3300.