Orthofix MJ-FLEX THE NEW METAIZEAU NAIL
FDA 510(k) K173051 · Orthofix Srl
510(k) numberK173051
Submission
- Device name
- Orthofix MJ-FLEX THE NEW METAIZEAU NAIL
- Applicant
- Orthofix Srl
Bussolengo, IT - Received
- September 28, 2017
- Decision date
- November 16, 2017
- 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 Orthofix MJ-FLEX THE NEW METAIZEAU NAIL cleared by the FDA?
Orthofix MJ-FLEX THE NEW METAIZEAU NAIL (K173051) received a 510(k) decision of Substantially Equivalent on November 16, 2017, 49 days after the submission was received.
What is the product code of K173051?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.