Modification to Hedrocel Trabecular Metal Reconstruction System
FDA 510(k) K032282 · Implex Corp.
510(k) numberK032282
Submission
- Device name
- Modification to Hedrocel Trabecular Metal Reconstruction System
- Applicant
- Implex Corp.
Allendale, NJ, US - Received
- July 24, 2003
- Decision date
- August 21, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
| K900138 | Motech Titanium Surgical MeshEZX · Traditional | Biedermann Motech GmbH | 03/20/1990SE |
| K896369 | Titanium Mesh Maxillofacial Implant SystemEZX · Traditional | Techmedica, Inc. | 11/24/1989SE |
More from Techmedica, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K051978 | Trabecular Metal Vertebral Body ReplacementMQP · Special | 09/23/2005SE |
| K051196 | Trabecular Metal Vertebral Body Replacement, Model 06-165-011X1 and 06-166-051X1MQP · Special | 06/17/2005SE |
| K040487 | Trabecular Metal Knee System AugmentsMBH · Traditional | 12/21/2004SE |
| K040630 | Trabecular Metal Femoral Cone Augments, Model 03-125-ZZZZJWH · Traditional | 09/30/2004SE |
| K040756 | The Trabecular Metal Reconstruction System, Model 10-340-XXXXXFTM · Special | 07/14/2004SE |
| K031962 | Nexgen Trabecular Metal Tibial Cone AugmentsJWH · Traditional | 01/08/2004SE |
| K033384 | The Hedrocel Trabecular Metal Reconstruction System, Model 06-165-ZZZZJDK · Special | 11/19/2003SE |
| K032527 | Hedrocel Vertebral Body ReplacementMQP · Special | 10/31/2003SE |
| K032344 | The Hedrocel Trabecular Metal Reconstruction System Model 10-330EZX · Special | 10/02/2003SE |
| K031449 | Modification to the Trabecular Metal Glenoid - Bigliani/Flatow the Complete Shoulder…KWS · Traditional | 09/23/2003SE |
Questions and answers
When was Modification to Hedrocel Trabecular Metal Reconstruction System cleared by the FDA?
Modification to Hedrocel Trabecular Metal Reconstruction System (K032282) received a 510(k) decision of Substantially Equivalent on August 21, 2003, 28 days after the submission was received.
What is the product code of K032282?
The FDA product code is EZX – Mesh, Surgical, Metal, a Class II (moderate risk) device regulated under 21 CFR 878.3300.