Dynamic Compression Shape Memory Alloy (Sma) Staple System
FDA 510(k) K012081 · Medtronic Sofamor Danek, Inc.
510(k) numberK012081
Submission
- Device name
- Dynamic Compression Shape Memory Alloy (Sma) Staple System
- Applicant
- Medtronic Sofamor Danek, Inc.
Memphis, TN, US - Received
- July 3, 2001
- Decision date
- October 1, 2001
- 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 Dynamic Compression Shape Memory Alloy (Sma) Staple System cleared by the FDA?
Dynamic Compression Shape Memory Alloy (Sma) Staple System (K012081) received a 510(k) decision of Substantially Equivalent on October 1, 2001, 90 days after the submission was received.
What is the product code of K012081?
The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.