Lite Decompression System- Light Cable Model 48089999
FDA 510(k) K122637 · Stryker Spine
510(k) numberK122637
Submission
- Device name
- Lite Decompression System- Light Cable Model 48089999
- Applicant
- Stryker Spine
Allendale, NJ, US - Received
- August 29, 2012
- Decision date
- November 1, 2012
- 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 Lite Decompression System- Light Cable Model 48089999 cleared by the FDA?
Lite Decompression System- Light Cable Model 48089999 (K122637) received a 510(k) decision of Substantially Equivalent on November 1, 2012, 64 days after the submission was received.
What is the product code of K122637?
The FDA product code is FST – Light, Surgical, Fiberoptic, a Class II (moderate risk) device regulated under 21 CFR 878.4580.