Trochanter Mesh
FDA 510(k) K945027 · Acu Med, Inc.
510(k) numberK945027
Submission
- Device name
- Trochanter Mesh
- Applicant
- Acu Med, Inc.
Beaverton, OR, US - Received
- October 13, 1994
- Decision date
- February 1, 1995
- Decision
- Substantially Equivalent for Some Indications (SN)
- 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 |
| 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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| K012655 | Congruent Bone Plate SystemHRS · Traditional | 11/07/2001SE |
| K992525 | Acumed Modular Shoulder SystemHSD · Traditional | 02/04/2000SE |
| K993657 | Acumed Suture AnchorMBI · Traditional | 01/13/2000SE |
| K980103 | Acumed Suture AnchorMBI · Traditional | 03/16/1998SE |
| K965028 | Acumed Suture WasherHTN · Traditional | 03/17/1997SE |
| K965029 | Stableloc II External FixatorJEC · Traditional | 02/19/1997SE |
| K964500 | Acumed Tension Band PinHTY · Traditional | 12/09/1996SE |
| K963026 | TBDHSB · Traditional | 10/28/1996SE |
Questions and answers
When was Trochanter Mesh cleared by the FDA?
Trochanter Mesh (K945027) received a 510(k) decision of Substantially Equivalent for Some Indications on February 1, 1995, 111 days after the submission was received.
What is the product code of K945027?
The FDA product code is EZX – Mesh, Surgical, Metal, a Class II (moderate risk) device regulated under 21 CFR 878.3300.