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FDA 510(k)

TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM

K-Number: K013775 · 2002-01-08

ApplicantStryker Leibinger
Decision Date2002-01-08
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Leibinger. It received FDA 510(k) clearance on 2002-01-08 under 510(k) number K013775. 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 TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM?

TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2002-01-08. The listed applicant is Stryker Leibinger. The 510(k) number is K013775.

When did TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM receive FDA 510(k) clearance?

TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM received FDA 510(k) clearance on 2002-01-08, under 510(k) number K013775.

Who is the listed applicant for TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM?

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

What is the FDA product code for TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM?

The FDA product code for TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM is HRS.

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Other records listing Stryker Leibinger 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.

K052871STRYKER CUSTOM TI IMPLANTK043250STRYKER PATIENT SPECIFIC POLYMER IMPLANTK041651STRYKER LEIBINGER SKELETAL ANCHORING SYSTEMK040022STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEMK022579STRYKER NAVIGATION SYSTEM-KNEE MODULEK023449NON-INVASIVE PATIENT FIXATION SYSTEM

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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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