Arthrex Crosspin, Model AR-1964P
FDA 510(k) K063719 · Arthrex, Inc.
510(k) numberK063719
Submission
- Device name
- Arthrex Crosspin, Model AR-1964P
- Applicant
- Arthrex, Inc.
Naples, FL, US - Received
- December 15, 2006
- Decision date
- March 6, 2007
- 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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| K254215 | Arthrex Beaming SystemHWC · Traditional | 05/08/2026SE |
| K260561 | Arthrex FiberTak Suture AnchorMBI · Special | 03/20/2026SE |
| K252016 | Arthrex Humeral NailsHSB · Traditional | 03/20/2026SE |
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Questions and answers
When was Arthrex Crosspin, Model AR-1964P cleared by the FDA?
Arthrex Crosspin, Model AR-1964P (K063719) received a 510(k) decision of Substantially Equivalent on March 6, 2007, 81 days after the submission was received.
What is the product code of K063719?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.