Mitek Micro Quickanchor
FDA 510(k) K032078 · Mitek Worldwide
510(k) numberK032078
Submission
- Device name
- Mitek Micro Quickanchor
- Applicant
- Mitek Worldwide
Norwood, MA, US - Received
- July 7, 2003
- Decision date
- August 25, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NOV – Anchor, Suture, Bone Fixation, Metallic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
This device is indicated for attaching suture into bone for suspension of the nasal valve and for attaching suture into bone at the lower orbital rim.
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Questions and answers
When was Mitek Micro Quickanchor cleared by the FDA?
Mitek Micro Quickanchor (K032078) received a 510(k) decision of Substantially Equivalent on August 25, 2003, 49 days after the submission was received.
What is the product code of K032078?
The FDA product code is NOV – Anchor, Suture, Bone Fixation, Metallic, a Class II (moderate risk) device regulated under 21 CFR 888.3030.