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FDA 510(k)

FIXATION DEVICES AND BONE PLATE

K-Number: K913930 · 1991-10-04

ApplicantJohn M. Rayhack
Decision Date1991-10-04
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FIXATION DEVICES AND BONE PLATE is the device name listed in this FDA 510(k) record. The listed applicant is John M. Rayhack. It received FDA 510(k) clearance on 1991-10-04 under 510(k) number K913930. 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 FIXATION DEVICES AND BONE PLATE?

FIXATION DEVICES AND BONE PLATE is a medical device that received FDA 510(k) clearance on 1991-10-04. The listed applicant is John M. Rayhack. The 510(k) number is K913930.

When did FIXATION DEVICES AND BONE PLATE receive FDA 510(k) clearance?

FIXATION DEVICES AND BONE PLATE received FDA 510(k) clearance on 1991-10-04, under 510(k) number K913930.

Who is the listed applicant for FIXATION DEVICES AND BONE PLATE?

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

What is the FDA product code for FIXATION DEVICES AND BONE PLATE?

The FDA product code for FIXATION DEVICES AND BONE PLATE is HRS.

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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

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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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