Legend Power Adapter Model: 6475000
FDA 510(k) K101168 · Medtronic Sofamor Danek
510(k) numberK101168
Submission
- Device name
- Legend Power Adapter Model: 6475000
- Applicant
- Medtronic Sofamor Danek
Memphis, TN, US - Received
- April 26, 2010
- Decision date
- August 24, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Legend Power Adapter Model: 6475000 cleared by the FDA?
Legend Power Adapter Model: 6475000 (K101168) received a 510(k) decision of Substantially Equivalent on August 24, 2010, 120 days after the submission was received.
What is the product code of K101168?
The FDA product code is HBB – Motor, Drill, Pneumatic, a Class II (moderate risk) device regulated under 21 CFR 882.4370.