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FDA 510(k)

HAWAIIAN SUPRACONDYLAR PLATE

K-Number: K903697 · 1991-01-15

ApplicantMedpac
Decision Date1991-01-15
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HAWAIIAN SUPRACONDYLAR PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Medpac. It received FDA 510(k) clearance on 1991-01-15 under 510(k) number K903697. 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 HAWAIIAN SUPRACONDYLAR PLATE?

HAWAIIAN SUPRACONDYLAR PLATE is a medical device that received FDA 510(k) clearance on 1991-01-15. The listed applicant is Medpac. The 510(k) number is K903697.

When did HAWAIIAN SUPRACONDYLAR PLATE receive FDA 510(k) clearance?

HAWAIIAN SUPRACONDYLAR PLATE received FDA 510(k) clearance on 1991-01-15, under 510(k) number K903697.

Who is the listed applicant for HAWAIIAN SUPRACONDYLAR PLATE?

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

What is the FDA product code for HAWAIIAN SUPRACONDYLAR PLATE?

The FDA product code for HAWAIIAN SUPRACONDYLAR 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 Medpac 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.

K951303SFCK951302SMALL FRAGMENT PLATES AND SCREWS

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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