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FDA 510(k)

INTEGRA PROXIMAL HUMERAL PLATE SYSTEM

K-Number: K121826 · 2013-02-13

ApplicantAscension Orthopedics, Inc.
Decision Date2013-02-13
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INTEGRA PROXIMAL HUMERAL PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ascension Orthopedics, Inc.. It received FDA 510(k) clearance on 2013-02-13 under 510(k) number K121826. 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 INTEGRA PROXIMAL HUMERAL PLATE SYSTEM?

INTEGRA PROXIMAL HUMERAL PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2013-02-13. The listed applicant is Ascension Orthopedics, Inc.. The 510(k) number is K121826.

When did INTEGRA PROXIMAL HUMERAL PLATE SYSTEM receive FDA 510(k) clearance?

INTEGRA PROXIMAL HUMERAL PLATE SYSTEM received FDA 510(k) clearance on 2013-02-13, under 510(k) number K121826.

Who is the listed applicant for INTEGRA PROXIMAL HUMERAL PLATE SYSTEM?

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

What is the FDA product code for INTEGRA PROXIMAL HUMERAL PLATE SYSTEM?

The FDA product code for INTEGRA PROXIMAL HUMERAL PLATE SYSTEM is HRS.

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Other records listing Ascension Orthopedics, 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.

K233674Freedom Wrist Arthroplasty SystemK233670Ascension Silicone MCP; Ascension Silicone PIPK110700ASCENSION ATLAS HUMERAL PLATING SYSTEMK102549THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTYK100448ASCENSION MODULAR TOTAL SHOULDER SYSTEMK100502ASCENSION TOTAL PLATE SYSTEM

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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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