DeviceClearance

Q Pedicle Instruments— 510(k) K260546

Substantially Equivalent

K2m, Inc.

FDA 510(k) clearance K260546 for Q Pedicle Instruments, Substantially Equivalent on 2026-03-17. Applicant: K2m, Inc.. Device class: 2.

Summary

K2m's Q Pedicle Instruments are filed under OLO, orthopedic stereotaxic instruments. The record doesn't list the individual instruments.

Class II, 21 CFR 882.4560. The Orthopedic review panel handled it as a Special 510(k), though the record lists Neurology as the classification panel.

K2m filed from Leesburg, Virginia. The decision came 27 calendar days after receipt (February 18 to March 17, 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
Special
Location
Leesburg, VA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code OLO

view all

More clearances from K2m, Inc.

view all

Adverse 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.