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FDA 510(k)

Tempo Plating System; Ultra Compression Screw System

K-Number: K261647 · 2026-09-03

ApplicantPace Surgical
Decision Date2026-09-03
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tempo Plating System; Ultra Compression Screw 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 2026-09-03 under 510(k) number K261647. 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; Ultra Compression Screw System?

Tempo Plating System; Ultra Compression Screw System is a medical device that received FDA 510(k) clearance on 2026-09-03. The listed applicant is Pace Surgical. The 510(k) number is K261647.

When did Tempo Plating System; Ultra Compression Screw System receive FDA 510(k) clearance?

Tempo Plating System; Ultra Compression Screw System received FDA 510(k) clearance on 2026-09-03, under 510(k) number K261647.

Who is the listed applicant for Tempo Plating System; Ultra Compression Screw 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; Ultra Compression Screw System?

The FDA product code for Tempo Plating System; Ultra Compression Screw System is HRS.

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.

K251555Ultra™ 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.

K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim SirketiK262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.

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.

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