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FDA 510(k)

POLYETHYLENE FILLED BONE PLATE

K-Number: K801603 · 1980-10-03

ApplicantZimmer, Inc.
Decision Date1980-10-03
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

POLYETHYLENE FILLED BONE PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 1980-10-03 under 510(k) number K801603. 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 POLYETHYLENE FILLED BONE PLATE?

POLYETHYLENE FILLED BONE PLATE is a medical device that received FDA 510(k) clearance on 1980-10-03. The listed applicant is Zimmer, Inc.. The 510(k) number is K801603.

When did POLYETHYLENE FILLED BONE PLATE receive FDA 510(k) clearance?

POLYETHYLENE FILLED BONE PLATE received FDA 510(k) clearance on 1980-10-03, under 510(k) number K801603.

Who is the listed applicant for POLYETHYLENE FILLED BONE PLATE?

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

What is the FDA product code for POLYETHYLENE FILLED BONE PLATE?

The FDA product code for POLYETHYLENE FILLED 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

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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