Hoffmann LRF (Limb Reconstruction Frame) System
FDA 510(k) K140961 · Stryker Trauma AG
510(k) numberK140961
Submission
- Device name
- Hoffmann LRF (Limb Reconstruction Frame) System
- Applicant
- Stryker Trauma AG
Selzach, CH - Received
- April 15, 2014
- Decision date
- November 10, 2014
- 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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| K252106 | External Fixation Mini Rail SystemKTT · Traditional | Paragon 28, Inc. | 09/30/2025SE |
| K251862 | External Fixation Bone DistractorKTT · Traditional | Paragon 28, Inc. | 08/11/2025SE |
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Questions and answers
When was Hoffmann LRF (Limb Reconstruction Frame) System cleared by the FDA?
Hoffmann LRF (Limb Reconstruction Frame) System (K140961) received a 510(k) decision of Substantially Equivalent on November 10, 2014, 209 days after the submission was received.
What is the product code of K140961?
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.