Conserve Pressfit Femoral Component
FDA 510(k) K082673 · Wrightmedicaltechnologyinc
510(k) numberK082673
Submission
- Device name
- Conserve Pressfit Femoral Component
- Applicant
- Wrightmedicaltechnologyinc
Arlington, TN, US - Received
- September 15, 2008
- Decision date
- December 12, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KXA – Prosthesis, Hip, Femoral, Resurfacing
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3400
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KXA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201219 | Biocore9 Femoral Head Resurfacing ComponentKXA · Traditional | Biocore9, LLC | 01/19/2021SE |
| K092198 | Cormet Cementless Resurfacing Femoral HeadKXA · Traditional | Corin USA | 04/15/2010SE |
| K071053 | Recap Ha Press-Fit Femoral Resurfacing HeadKXA · Special | Biomet, Inc. | 06/29/2007SE |
| K070292 | Durom Hip Resurfacing System, Femoral ComponentsKXA · Traditional | Zimmer GmbH | 04/26/2007SE |
| K062960 | Conserve Femoral Resurfacing ComponentKXA · Special | Wrightmedicaltechnologyinc | 12/01/2006SE |
| K043542 | Biopro Tara Femoral Resurfacing ComponentKXA · Traditional | Biopro, Inc. | 05/18/2005SE |
| K032659 | Depuy Asr Resurfacing Femoral HeadsKXA · Traditional | DePuy Orthopaedics, Inc. | 12/04/2003SE |
| K023188 | Press-Fit Head Resurfacing DeviceKXA · Traditional | Biomet Orthopedics, Inc. | 12/11/2002SE |
| K021549 | Contoured Articular Prosthesis (Cap) Femoral Head Resurfacing SystemKXA · Traditional | Std Mfg., Inc. | 08/01/2002SE |
| K021799 | Cemented Femoral Head Resurfing DeviceKXA · Special | Biomet Orthopedics, Inc. | 06/26/2002SE |
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Questions and answers
When was Conserve Pressfit Femoral Component cleared by the FDA?
Conserve Pressfit Femoral Component (K082673) received a 510(k) decision of Substantially Equivalent on December 12, 2008, 88 days after the submission was received.
What is the product code of K082673?
The FDA product code is KXA – Prosthesis, Hip, Femoral, Resurfacing, a Class II (moderate risk) device regulated under 21 CFR 888.3400.