510(k) K122637
K122637 is an FDA 510(k) premarket notification submitted by Stryker Spine for the device "LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999". The FDA issued a decision of Substantially Equivalent on November 1, 2012. The device falls under product code FST (Light, Surgical, Fiberoptic), a Class II device regulated under 21 CFR 878.4580. Stryker Spine has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 1, 2012
- Date Received
- August 29, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Surgical, Fiberoptic
- Device Class
- Class II
- Regulation Number
- 878.4580
- Review Panel
- SU
- Submission Type