Axxion Light Guide
FDA 510(k) K082992 · Spinal Elements, Inc.
510(k) numberK082992
Submission
- Device name
- Axxion Light Guide
- Applicant
- Spinal Elements, Inc.
Carlsbad, CA, US - Received
- October 7, 2008
- Decision date
- February 18, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FST – Light, Surgical, Fiberoptic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Specialty
- General, Plastic Surgery
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Questions and answers
When was Axxion Light Guide cleared by the FDA?
Axxion Light Guide (K082992) received a 510(k) decision of Substantially Equivalent on February 18, 2009, 134 days after the submission was received.
What is the product code of K082992?
The FDA product code is FST – Light, Surgical, Fiberoptic, a Class II (moderate risk) device regulated under 21 CFR 878.4580.