Nelson Resurfacing Head
FDA 510(k) K983452 · Biomet, Inc.
510(k) numberK983452
Submission
- Device name
- Nelson Resurfacing Head
- Applicant
- Biomet, Inc.
Warsaw, IN, US - Received
- September 30, 1998
- Decision date
- December 3, 1998
- 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 |
| 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 |
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| K241014 | Biomet Kirschner Wires (K-Wires)HTY · Traditional | 05/22/2024SE |
| K222760 | StageOne Select Hip Cement Spacer MoldsMBB · Traditional | 12/28/2022SE |
| K221968 | StageOne Shoulder Cement Spacer MoldsMBB · Traditional | 09/15/2022SE |
| K213287 | StageOne Knee Cement Spacer MoldsMBB · Traditional | 09/02/2022SE |
| K212431 | Biomet Answer/Impact/Integral Distal Centralizer/Centering SleeveJDG · Traditional | 02/07/2022SE |
| K212435 | Comprehensive Humeral Fracture Positioning SleevesKWS · Traditional | 12/10/2021SE |
| K210192 | A.L.P.S. Clavicle Plating SystemHRS · Special | 02/19/2021SE |
| K193214 | WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…MBI · Traditional | 11/10/2020SE |
Questions and answers
When was Nelson Resurfacing Head cleared by the FDA?
Nelson Resurfacing Head (K983452) received a 510(k) decision of Substantially Equivalent on December 3, 1998, 64 days after the submission was received.
What is the product code of K983452?
The FDA product code is KXA – Prosthesis, Hip, Femoral, Resurfacing, a Class II (moderate risk) device regulated under 21 CFR 888.3400.