Conmed Linvatec Osprey Drill System
FDA 510(k) K080444 · Conmed Linvatec
510(k) numberK080444
Submission
- Device name
- Conmed Linvatec Osprey Drill System
- Applicant
- Conmed Linvatec
Largo, FL, US - Received
- February 19, 2008
- Decision date
- April 2, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Conmed Linvatec Osprey Drill System cleared by the FDA?
Conmed Linvatec Osprey Drill System (K080444) received a 510(k) decision of Substantially Equivalent on April 2, 2008, 43 days after the submission was received.
What is the product code of K080444?
The FDA product code is HBC – Motor, Drill, Electric, a Class II (moderate risk) device regulated under 21 CFR 882.4360.