Magellan Magnetic Distal Targeting System(Proposed Name), Product Line Extension
FDA 510(k) K971056 · Wrightmedicaltechnologyinc
510(k) numberK971056
Submission
- Device name
- Magellan Magnetic Distal Targeting System(Proposed Name), Product Line Extension
- Applicant
- Wrightmedicaltechnologyinc
Arlington, TN, US - Received
- March 24, 1997
- Decision date
- October 3, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3020
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Magellan Magnetic Distal Targeting System(Proposed Name), Product Line Extension cleared by the FDA?
Magellan Magnetic Distal Targeting System(Proposed Name), Product Line Extension (K971056) received a 510(k) decision of Substantially Equivalent on October 3, 1997, 193 days after the submission was received.
What is the product code of K971056?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.