Q Interbody Instruments— 510(k) K252873
Substantially EquivalentK2m, Inc.
FDA 510(k) clearance K252873 for Q Interbody Instruments, Substantially Equivalent on 2026-02-06. Applicant: K2m, Inc.. Device class: 2.
Summary
K2m's Q Interbody Instruments are filed under product code OLO, orthopedic stereotaxic instrument. The record doesn't describe the instruments beyond their name and that code name.
Class II, 21 CFR 882.4560. The Orthopedic review panel handled it as a Traditional 510(k), though the record lists Neurology as the classification panel.
K2m filed from Leesburg, Virginia. The substantially equivalent decision came 149 calendar days after receipt (September 10, 2025 to February 6, 2026).
Clearance details
- Applicant
- K2m, Inc.
- Product code
- Product code OLO
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Leesburg, VA, US
Recent devices under product code OLO
view allMore clearances from K2m, Inc.
view allAdverse events under product code OLO
product code OLO- Death
- 11
- Injury
- 2,799
- Malfunction
- 11,105
- Other
- 1
- Total
- 13,916
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.