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FDA 510(k)

POSTERIOR LATERAL PLATES

K-Number: K103408 · 2010-12-16

ApplicantDePuy Orthopaedics, Inc.
Decision Date2010-12-16
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

POSTERIOR LATERAL PLATES is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2010-12-16 under 510(k) number K103408. 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 POSTERIOR LATERAL PLATES?

POSTERIOR LATERAL PLATES is a medical device that received FDA 510(k) clearance on 2010-12-16. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K103408.

When did POSTERIOR LATERAL PLATES receive FDA 510(k) clearance?

POSTERIOR LATERAL PLATES received FDA 510(k) clearance on 2010-12-16, under 510(k) number K103408.

Who is the listed applicant for POSTERIOR LATERAL PLATES?

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

What is the FDA product code for POSTERIOR LATERAL PLATES?

The FDA product code for POSTERIOR LATERAL PLATES is HRS.

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Related Devices (Code: HRS)

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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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