Howmedica Mainstay Anchor
FDA 510(k) K965175 · Howmedica Corp.
510(k) numberK965175
Submission
- Device name
- Howmedica Mainstay Anchor
- Applicant
- Howmedica Corp.
Rutherford, NJ, US - Received
- December 24, 1996
- Decision date
- March 13, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 Howmedica Mainstay Anchor cleared by the FDA?
Howmedica Mainstay Anchor (K965175) received a 510(k) decision of Substantially Equivalent on March 13, 1997, 79 days after the submission was received.
What is the product code of K965175?
The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.