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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is K2m, Inc.. It received FDA 510(k) clearance on 2026-03-17 under 510(k) 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. The listed applicant is K2m, Inc.. The 510(k) number is K260546.

When did Q Pedicle Instruments receive FDA 510(k) clearance?

Q Pedicle Instruments received FDA 510(k) clearance on 2026-03-17, under 510(k) number K260546.

Who is the listed applicant for Q Pedicle Instruments?

The FDA 510(k) record lists K2m, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Q Pedicle Instruments?

The FDA product code for Q Pedicle Instruments is OLO.

Other records listing K2m, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 43 devices →

Related Devices (Code: OLO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.