Memory Metal Staples, Easyclip
FDA 510(k) K122113 · Stryker Corp.
510(k) numberK122113
Submission
- Device name
- Memory Metal Staples, Easyclip
- Applicant
- Stryker Corp.
Mahwah, NJ, US - Received
- July 17, 2012
- Decision date
- March 12, 2013
- 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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| K232990 | ATOMIC Nitinol Fixation SystemJDR · Traditional | Rmr Ortho, LLC | 01/12/2024SE |
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Questions and answers
When was Memory Metal Staples, Easyclip cleared by the FDA?
Memory Metal Staples, Easyclip (K122113) received a 510(k) decision of Substantially Equivalent on March 12, 2013, 238 days after the submission was received.
What is the product code of K122113?
The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.