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FDA 510(k)

PIONEER STERNAL ASSIST IMPLANT SYSTEM

K-Number: K120016 · 2012-07-26

ApplicantPioneer Surgical Technology, Inc.
Decision Date2012-07-26
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PIONEER STERNAL ASSIST IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pioneer Surgical Technology, Inc.. It received FDA 510(k) clearance on 2012-07-26 under 510(k) number K120016. 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 PIONEER STERNAL ASSIST IMPLANT SYSTEM?

PIONEER STERNAL ASSIST IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2012-07-26. The listed applicant is Pioneer Surgical Technology, Inc.. The 510(k) number is K120016.

When did PIONEER STERNAL ASSIST IMPLANT SYSTEM receive FDA 510(k) clearance?

PIONEER STERNAL ASSIST IMPLANT SYSTEM received FDA 510(k) clearance on 2012-07-26, under 510(k) number K120016.

Who is the listed applicant for PIONEER STERNAL ASSIST IMPLANT SYSTEM?

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

What is the FDA product code for PIONEER STERNAL ASSIST IMPLANT SYSTEM?

The FDA product code for PIONEER STERNAL ASSIST IMPLANT SYSTEM is HRS.

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Other records listing Pioneer Surgical Technology, Inc. as applicant

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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.

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical TechnologiesK262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace SurgicalK261830FRAXION 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.

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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