Conserve Femoral Resurfacing Component
FDA 510(k) K062960 · Wrightmedicaltechnologyinc
510(k) numberK062960
Submission
- Device name
- Conserve Femoral Resurfacing Component
- Applicant
- Wrightmedicaltechnologyinc
Arlington, TN, US - Received
- September 29, 2006
- Decision date
- December 1, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| K082673 | Conserve Pressfit Femoral ComponentKXA · Traditional | Wrightmedicaltechnologyinc | 12/12/2008SE |
| 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 |
| 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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| K212996 | Sterile PHALINX Hammertoe SystemHWC · Traditional | 11/16/2021SE |
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| K200507 | PRO-DENSE LoVisc Bone Graft SubstituteMQV · Traditional | 10/21/2020SE |
| K193067 | The INBONE Total Ankle System, the INFINITY Total Ankle System and the INVISION Total…HSN · Traditional | 06/08/2020SE |
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Questions and answers
When was Conserve Femoral Resurfacing Component cleared by the FDA?
Conserve Femoral Resurfacing Component (K062960) received a 510(k) decision of Substantially Equivalent on December 1, 2006, 63 days after the submission was received.
What is the product code of K062960?
The FDA product code is KXA – Prosthesis, Hip, Femoral, Resurfacing, a Class II (moderate risk) device regulated under 21 CFR 888.3400.