Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece
K240662 is the FDA 510(k) clearance record for Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece, a class II device, cleared for Stryker Leibinger GmbH & Co KG on under FDA product code OLO (Orthopedic Stereotaxic Instrument). FDA's definition for product code OLO reads: "Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW". FDA records list 22 510(k) clearances for Stryker Leibinger GmbH & Co KG, from to . As of , FDA records show no recalls naming K240662.
Clearance record
- Decision date
- Received
- (90 days to decision)
- Product code
- OLO Orthopedic Stereotaxic Instrument
- Regulation
- 21 CFR 882.4560
- Device class
- Class II
- Review panel
- Neurology
- Applicant
- Stryker Leibinger GmbH & Co KG Bötzinger Straße 41, Freiburg Im Breisgau, DE
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code OLO
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 2 |
| December 2025 | 4 |
| January 2026 | 2 |
| February 2026 | 10 |
| March 2026 | 7 |
| April 2026 | 2 |
| May 2026 | 5 |
| June 2026 | 5 |
| July 2026 | 6 |
| August 2026 | 1 |
| September 2026 | 0 |
| October 2026 | 0 |
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