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FDA 510(k)

LACTOSORB PLATES, MESHES, AND PANELS/SHEETS

K-Number: K011237 · 2001-05-23

ApplicantBiomet, Inc.
Decision Date2001-05-23
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LACTOSORB PLATES, MESHES, AND PANELS/SHEETS is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2001-05-23 under 510(k) number K011237. 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 LACTOSORB PLATES, MESHES, AND PANELS/SHEETS?

LACTOSORB PLATES, MESHES, AND PANELS/SHEETS is a medical device that received FDA 510(k) clearance on 2001-05-23. The listed applicant is Biomet, Inc.. The 510(k) number is K011237.

When did LACTOSORB PLATES, MESHES, AND PANELS/SHEETS receive FDA 510(k) clearance?

LACTOSORB PLATES, MESHES, AND PANELS/SHEETS received FDA 510(k) clearance on 2001-05-23, under 510(k) number K011237.

Who is the listed applicant for LACTOSORB PLATES, MESHES, AND PANELS/SHEETS?

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

What is the FDA product code for LACTOSORB PLATES, MESHES, AND PANELS/SHEETS?

The FDA product code for LACTOSORB PLATES, MESHES, AND PANELS/SHEETS 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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