Cormet Cementless Resurfacing Femoral Head
FDA 510(k) K092198 · Corin USA
510(k) numberK092198
Submission
- Device name
- Cormet Cementless Resurfacing Femoral Head
- Applicant
- Corin USA
Tampa, FL, US - Received
- July 21, 2009
- Decision date
- April 15, 2010
- 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 |
| 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 |
| 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 |
More from Biomet Orthopedics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K203751 | OMNIVision systemOLO · Traditional | 04/12/2021SE |
| K202805 | Optimized Positioning System (OPS) InsightLLZ · Traditional | 11/20/2020SE |
| K193545 | Corin Optimized Positioning System (OPS) FemoralLZO · Traditional | 08/04/2020SE |
| K193042 | Optimized Positioning System (OPS) ReViewLLZ · Traditional | 06/26/2020SE |
| K192656 | Optimized Positioning System (OPS) InsightLLZ · Traditional | 05/01/2020SE |
| K190143 | LARS AC Band DeviceHTN · Traditional | 11/04/2019SE |
| K190834 | Corin Optimized Position System Functional Hip Analysis (OPS FHA)LZO · Traditional | 07/22/2019SE |
| K183038 | Corin Optimized Positioning System (OPS) PlanLLZ · Traditional | 11/26/2018SE |
| K181061 | Corin Optimized Positioning System (OPS) FemoralLZO · Traditional | 09/07/2018SE |
| K152893 | Corin Optimized Positioning System (OPS)LZO · Traditional | 06/03/2016SE |
Questions and answers
When was Cormet Cementless Resurfacing Femoral Head cleared by the FDA?
Cormet Cementless Resurfacing Femoral Head (K092198) received a 510(k) decision of Substantially Equivalent on April 15, 2010, 268 days after the submission was received.
What is the product code of K092198?
The FDA product code is KXA – Prosthesis, Hip, Femoral, Resurfacing, a Class II (moderate risk) device regulated under 21 CFR 888.3400.