Synthes Quick Lock Imf System
FDA 510(k) K991004 · Synthes (Usa)
510(k) numberK991004
Submission
- Device name
- Synthes Quick Lock Imf System
- Applicant
- Synthes (Usa)
Paoli, PA, US - Received
- March 25, 1999
- Decision date
- June 23, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Synthes Quick Lock Imf System cleared by the FDA?
Synthes Quick Lock Imf System (K991004) received a 510(k) decision of Substantially Equivalent on June 23, 1999, 90 days after the submission was received.
What is the product code of K991004?
The FDA product code is DYX – Lock, Wire, And Ligature, Intraoral, a Class II (moderate risk) device regulated under 21 CFR 872.4600.