Bone Fixation Wire (Kirschner Wire)
FDA 510(k) K073674 · Signal Medical Corp.
510(k) numberK073674
Submission
- Device name
- Bone Fixation Wire (Kirschner Wire)
- Applicant
- Signal Medical Corp.
Marysville, MI, US - Received
- December 28, 2007
- Decision date
- March 24, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HTY – Pin, Fixation, Smooth
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Bone Fixation Wire (Kirschner Wire) cleared by the FDA?
Bone Fixation Wire (Kirschner Wire) (K073674) received a 510(k) decision of Substantially Equivalent on March 24, 2008, 87 days after the submission was received.
What is the product code of K073674?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.