Csco Forehead Fixation System
FDA 510(k) K963502 · Howmedica Corp.
510(k) numberK963502
Submission
- Device name
- Csco Forehead Fixation System
- Applicant
- Howmedica Corp.
Dallas, TX, US - Received
- September 3, 1996
- Decision date
- October 28, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBI – Fastener, Fixation, Nondegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Csco Forehead Fixation System cleared by the FDA?
Csco Forehead Fixation System (K963502) received a 510(k) decision of Substantially Equivalent on October 28, 1997, 420 days after the submission was received.
What is the product code of K963502?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.