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FDA 510(k)

LUHR MINI BONE SCREW AND Z PLATE

K-Number: K935448 · 1994-02-23

ApplicantHowmedica Corp.
Decision Date1994-02-23
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

LUHR MINI BONE SCREW AND Z PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1994-02-23 under 510(k) number K935448. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the LUHR MINI BONE SCREW AND Z PLATE?

LUHR MINI BONE SCREW AND Z PLATE is a medical device that received FDA 510(k) clearance on 1994-02-23. The listed applicant is Howmedica Corp.. The 510(k) number is K935448.

When did LUHR MINI BONE SCREW AND Z PLATE receive FDA 510(k) clearance?

LUHR MINI BONE SCREW AND Z PLATE received FDA 510(k) clearance on 1994-02-23, under 510(k) number K935448.

Who is the listed applicant for LUHR MINI BONE SCREW AND Z PLATE?

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 LUHR MINI BONE SCREW AND Z PLATE?

The FDA product code for LUHR MINI BONE SCREW AND Z PLATE 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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