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FDA 510(k)

HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM

K-Number: K982531 · 1998-10-16

ApplicantHowmedica Corp.
Decision Date1998-10-16
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1998-10-16 under 510(k) number K982531. 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 HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM?

HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 1998-10-16. The listed applicant is Howmedica Corp.. The 510(k) number is K982531.

When did HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM receive FDA 510(k) clearance?

HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM received FDA 510(k) clearance on 1998-10-16, under 510(k) number K982531.

Who is the listed applicant for HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM?

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

What is the FDA product code for HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM?

The FDA product code for HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM is HRS.

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Other records listing Howmedica Corp. 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.

K983528MICRO DYNAMIC MESHK983404TYPE 3 FEMORAL COMPONENTSK980926DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATIONK980925DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATIONK980626DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATIONK980632DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION

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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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