Aequalis Humeral Plate
FDA 510(k) K063551 · Tornier
510(k) numberK063551
Submission
- Device name
- Aequalis Humeral Plate
- Applicant
- Tornier
Saint-Ismier Cedex, FR - Received
- November 24, 2006
- Decision date
- December 22, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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| 510(k) | Device | Decision |
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| K251686 | Tornier Humeral Reconstruction System Max (Tornier HRS Max)KWT · Traditional | 10/30/2025SE |
| K230352 | Tornier Humeral Nail and Tornier Long Humeral NailHSB · Traditional | 10/31/2023SE |
| K220914 | Tornier Perform Humeral System FracturePHX · Traditional | 10/14/2022SE |
| K220418 | Tornier Perform Humeral System StemlessPKC · Traditional | 09/14/2022SE |
| K211359 | Tornier Perform Patient-Matched Primary Reversed Glenoid and BLUEPRINT Patient…PHX · Traditional | 11/12/2021SE |
| K213124 | Tomier Perform Reversed Glenoid Cannulated GlenospheresPHX · Special | 10/26/2021SE |
| K201315 | PERFORM Humeral System StemPAO · Traditional | 09/11/2020SE |
| K193247 | LATITUDE EV Total Elbow ArthroplastyJDB · Traditional | 08/05/2020SE |
Questions and answers
When was Aequalis Humeral Plate cleared by the FDA?
Aequalis Humeral Plate (K063551) received a 510(k) decision of Substantially Equivalent on December 22, 2006, 28 days after the submission was received.
What is the product code of K063551?
The FDA product code is KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, a Class II (moderate risk) device regulated under 21 CFR 888.3030.