Synthes (USA) Trochanter Stabilization Plate for DHS
FDA 510(k) K000972 · Synthes (Usa)
510(k) numberK000972
Submission
- Device name
- Synthes (USA) Trochanter Stabilization Plate for DHS
- Applicant
- Synthes (Usa)
Paoli, PA, US - Received
- March 27, 2000
- Decision date
- June 16, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LXT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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| K060864 | Multidirectional Threaded PegLXT · Special | Hand Innovations, LLC | 04/28/2006SE |
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Questions and answers
When was Synthes (USA) Trochanter Stabilization Plate for DHS cleared by the FDA?
Synthes (USA) Trochanter Stabilization Plate for DHS (K000972) received a 510(k) decision of Substantially Equivalent on June 16, 2000, 81 days after the submission was received.
What is the product code of K000972?
The FDA product code is LXT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite, a Class II (moderate risk) device regulated under 21 CFR 888.3030.