Mecron Femoral Head W/Cone AS Unipolar or Bipolar
FDA 510(k) K844487 · Mecron Medical Products, Inc.
510(k) numberK844487
Submission
- Device name
- Mecron Femoral Head W/Cone AS Unipolar or Bipolar
- Applicant
- Mecron Medical Products, Inc.
Los Angeles, CA, US - Received
- November 19, 1984
- Decision date
- February 19, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KWL – Prosthesis, Hip, Hemi-, Femoral, Metal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3360
- Specialty
- Orthopedic
- Implant
- Yes
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| K253675 | OsteoRemedies Hip Spacer SystemKWL · Special | Osteoremedies, LLC | 12/23/2025SE |
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| K242865 | Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder SpacerKWL · Traditional | Biocomposites, Ltd. | 06/12/2025SE |
| K234028 | COPAL® exchange G hip spacer; COPAL® G+VKWL · Traditional | Heraeus Medical GmbH | 02/15/2024SE |
| K222632 | UHR Bipolar Implants, Restoration GAP II ImplantsKWL · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 10/21/2022SE |
| K192995 | OsteoRemedies Hip Spacer SystemKWL · Special | Osteoremedies, LLC | 01/10/2020SE |
| K191981 | REMEDY Acetabular CupKWL · Special | Osteoremedies, LLC | 08/23/2019SE |
| K172906 | REMEDY PLUS Hip Spacer, UNITE PLUS Bone CementKWL · Traditional | Osteoremedies, LLC | 08/29/2018SE |
More from Osteoremedies, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K861138 | Mash DermatomeGFD · Traditional | 04/14/1986SE |
| K854191 | Mecron Uncemented Structured Stem Hip · Traditional | 11/13/1985SE |
| K844775 | Effner-Eye Cautery with Battery HandleHQO · Traditional | 08/12/1985SE |
| K844774 | Effner Fiber Optic Cables for Cold Light TransmissFCR · Traditional | 04/22/1985SE |
| K844488 | Mecron Cemented Structured Stem Hip ProsthesisKWL · Traditional | 03/12/1985SE |
| K844486 | Mecron Mrc-Headless Femoral ComponentKWL · Traditional | 02/19/1985SE |
| K844773 | Eff-Effner BulbsFFS · Traditional | 01/08/1985SE |
| K843449 | Autodynamic Compression Hip Screw-PlateKTT · Traditional | 10/22/1984SE |
| K843554 | Bone ScrewsKTW · Traditional | 10/01/1984SE |
| K843553 | Bone PlatesKTW · Traditional | 10/01/1984SE |
Questions and answers
When was Mecron Femoral Head W/Cone AS Unipolar or Bipolar cleared by the FDA?
Mecron Femoral Head W/Cone AS Unipolar or Bipolar (K844487) received a 510(k) decision of Substantially Equivalent on February 19, 1985, 92 days after the submission was received.
What is the product code of K844487?
The FDA product code is KWL – Prosthesis, Hip, Hemi-, Femoral, Metal, a Class II (moderate risk) device regulated under 21 CFR 888.3360.