Super Quickanchor Plus
FDA 510(k) K041116 · Depuy Mitek
510(k) numberK041116
Submission
- Device name
- Super Quickanchor Plus
- Applicant
- Depuy Mitek
Norwood, MA, US - Received
- April 29, 2004
- Decision date
- May 28, 2004
- 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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Questions and answers
When was Super Quickanchor Plus cleared by the FDA?
Super Quickanchor Plus (K041116) received a 510(k) decision of Substantially Equivalent on May 28, 2004, 29 days after the submission was received.
What is the product code of K041116?
The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.