StealthFix Intraosseous Fixation System
FDA 510(k) K232324 · Medartis, Inc.
510(k) numberK232324
Submission
- Device name
- StealthFix Intraosseous Fixation System
- Applicant
- Medartis, Inc.
Warsaw, IN, US - Received
- August 3, 2023
- Decision date
- August 30, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDR – Staple, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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| K232990 | ATOMIC Nitinol Fixation SystemJDR · Traditional | Rmr Ortho, LLC | 01/12/2024SE |
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Questions and answers
When was StealthFix Intraosseous Fixation System cleared by the FDA?
StealthFix Intraosseous Fixation System (K232324) received a 510(k) decision of Substantially Equivalent on August 30, 2023, 27 days after the submission was received.
What is the product code of K232324?
The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.