Depuy Peak FX Hip Plate
FDA 510(k) K063509 · DePuy Orthopaedics, Inc.
510(k) numberK063509
Submission
- Device name
- Depuy Peak FX Hip Plate
- Applicant
- DePuy Orthopaedics, Inc.
Warsaw, IN, US - Received
- November 20, 2006
- Decision date
- January 4, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| K203167 | DePuy Corail AMT Hip ProsthesisLZO · Special | 11/19/2020SE |
| K202472 | ACTIS Duofix Hip ProsthesisLPH · Special | 10/21/2020SE |
| K201347 | DePuy ATTUNE Total Knee SystemOIY · Special | 06/18/2020SE |
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Questions and answers
When was Depuy Peak FX Hip Plate cleared by the FDA?
Depuy Peak FX Hip Plate (K063509) received a 510(k) decision of Substantially Equivalent on January 4, 2007, 45 days after the submission was received.
What is the product code of K063509?
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.