Humeral Staple
FDA 510(k) K041355 · Smith & Nephew, Inc.
510(k) numberK041355
Submission
- Device name
- Humeral Staple
- Applicant
- Smith & Nephew, Inc.
Cordova, TN, US - Received
- May 20, 2004
- Decision date
- July 30, 2004
- 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 Humeral Staple cleared by the FDA?
Humeral Staple (K041355) received a 510(k) decision of Substantially Equivalent on July 30, 2004, 71 days after the submission was received.
What is the product code of K041355?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.