Q Pedicle Instruments
K-Number: K260546 · 2026-03-17
ApplicantK2m, Inc.
Decision Date2026-03-17
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Q Pedicle Instruments is a medical device manufactured by K2m, Inc.. It received FDA 510(k) clearance on 2026-03-17 under approval number K260546. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Q Pedicle Instruments?
Q Pedicle Instruments is a medical device that received FDA 510(k) clearance on 2026-03-17. It is manufactured by K2m, Inc.. The 510(k) number is K260546.
When was Q Pedicle Instruments approved by the FDA?
Q Pedicle Instruments received FDA 510(k) clearance on 2026-03-17, under approval number K260546.
What company makes Q Pedicle Instruments?
Q Pedicle Instruments is manufactured by K2m, Inc..
What is the FDA product code for Q Pedicle Instruments?
The FDA product code for Q Pedicle Instruments is OLO.
Other Devices by K2m, Inc.
Related Devices (Code: OLO)
K162375Envision 3D: Image Guidance System7D Surgical, Inc.
K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG
K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc.
K160385Precision ScrewCryptych Pty, Ltd.
K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC
K153240Styrker OrthoMap Express Knee SystemStryker Corporate
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.