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FDA 510(k)

RADIUS OSTEOTOMY PLATES

K-Number: K914804 · 1992-04-29

ApplicantLink America, Inc.
Decision Date1992-04-29
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

RADIUS OSTEOTOMY PLATES is the device name listed in this FDA 510(k) record. The listed applicant is Link America, Inc.. It received FDA 510(k) clearance on 1992-04-29 under 510(k) number K914804. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the RADIUS OSTEOTOMY PLATES?

RADIUS OSTEOTOMY PLATES is a medical device that received FDA 510(k) clearance on 1992-04-29. The listed applicant is Link America, Inc.. The 510(k) number is K914804.

When did RADIUS OSTEOTOMY PLATES receive FDA 510(k) clearance?

RADIUS OSTEOTOMY PLATES received FDA 510(k) clearance on 1992-04-29, under 510(k) number K914804.

Who is the listed applicant for RADIUS OSTEOTOMY PLATES?

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

What is the FDA product code for RADIUS OSTEOTOMY PLATES?

The FDA product code for RADIUS OSTEOTOMY PLATES is HRS.

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Other records listing Link America, 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.

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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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