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FDA 510(k)

AFT PROXIMAL HUMERUS FRACTURE PLATE

K-Number: K121672 · 2012-10-01

ApplicantShoulder Options, Inc.
Decision Date2012-10-01
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AFT PROXIMAL HUMERUS FRACTURE PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Shoulder Options, Inc.. It received FDA 510(k) clearance on 2012-10-01 under 510(k) number K121672. 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 AFT PROXIMAL HUMERUS FRACTURE PLATE?

AFT PROXIMAL HUMERUS FRACTURE PLATE is a medical device that received FDA 510(k) clearance on 2012-10-01. The listed applicant is Shoulder Options, Inc.. The 510(k) number is K121672.

When did AFT PROXIMAL HUMERUS FRACTURE PLATE receive FDA 510(k) clearance?

AFT PROXIMAL HUMERUS FRACTURE PLATE received FDA 510(k) clearance on 2012-10-01, under 510(k) number K121672.

Who is the listed applicant for AFT PROXIMAL HUMERUS FRACTURE PLATE?

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

What is the FDA product code for AFT PROXIMAL HUMERUS FRACTURE PLATE?

The FDA product code for AFT PROXIMAL HUMERUS FRACTURE PLATE 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.

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Other records listing Shoulder Options, 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.

K102539ICUFF REPAIR PLATE, RIGHT; CUFF REPAIR PLATE. LEFT; ANCHOR BOLT, 10MM THROUGH 50MM

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

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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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