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FDA 510(k)

Tempo Plating System

K-Number: K263407 · 2026-10-23

ApplicantPace Surgical
Decision Date2026-10-23
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tempo Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Pace Surgical. It received FDA 510(k) clearance on 2026-10-23 under 510(k) number K263407. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tempo Plating System?

Tempo Plating System is a medical device that received FDA 510(k) clearance on 2026-10-23. The listed applicant is Pace Surgical. The 510(k) number is K263407.

When did Tempo Plating System receive FDA 510(k) clearance?

Tempo Plating System received FDA 510(k) clearance on 2026-10-23, under 510(k) number K263407.

Who is the listed applicant for Tempo Plating System?

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

What is the FDA product code for Tempo Plating System?

The FDA product code for Tempo Plating System is HRS.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Other records listing Pace Surgical 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.

K261647Tempo Plating System; Ultra Compression Screw SystemK251555Ultra™ Compression Screw System

Related Devices (Code: HRS)

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.

K262779ANTHEM™ Fracture SystemGlobus Medical, Inc.K263269Park's Pectus SystemTdm Co., Ltd.K261611TDM Large Bone Plate and Screw SystemTdm Co., Ltd.K262649Alians ForearmNewclip TechnicsK261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies

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.

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