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FDA 510(k)

DISTAL RADIUS FRACTURE FIXATION PLATE

K-Number: K981715 · 1998-07-29

ApplicantAvanta Orthopaedics, Inc.
Decision Date1998-07-29
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DISTAL RADIUS FRACTURE FIXATION PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Avanta Orthopaedics, Inc.. It received FDA 510(k) clearance on 1998-07-29 under 510(k) number K981715. 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 DISTAL RADIUS FRACTURE FIXATION PLATE?

DISTAL RADIUS FRACTURE FIXATION PLATE is a medical device that received FDA 510(k) clearance on 1998-07-29. The listed applicant is Avanta Orthopaedics, Inc.. The 510(k) number is K981715.

When did DISTAL RADIUS FRACTURE FIXATION PLATE receive FDA 510(k) clearance?

DISTAL RADIUS FRACTURE FIXATION PLATE received FDA 510(k) clearance on 1998-07-29, under 510(k) number K981715.

Who is the listed applicant for DISTAL RADIUS FRACTURE FIXATION PLATE?

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

What is the FDA product code for DISTAL RADIUS FRACTURE FIXATION PLATE?

The FDA product code for DISTAL RADIUS FRACTURE FIXATION PLATE is HRS.

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Other records listing Avanta Orthopaedics, 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.

K030881AVANTA CARPAL FUSION PLATING SYSTEMK021859WRIST IMPLANTK023604MODIFICATION TO RADIAL HEAD IMPLANTK013629FINGER JOINT PROSTHESISK011819RADIAL HEAD IMPLANTK010847K'FIX

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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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