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FDA 510(k)

NON-INVASIVE PATIENT FIXATION SYSTEM

K-Number: K023449 · 2003-01-13

ApplicantStryker Leibinger
Decision Date2003-01-13
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NON-INVASIVE PATIENT FIXATION 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 2003-01-13 under 510(k) number K023449. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NON-INVASIVE PATIENT FIXATION SYSTEM?

NON-INVASIVE PATIENT FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2003-01-13. The listed applicant is Stryker Leibinger. The 510(k) number is K023449.

When did NON-INVASIVE PATIENT FIXATION SYSTEM receive FDA 510(k) clearance?

NON-INVASIVE PATIENT FIXATION SYSTEM received FDA 510(k) clearance on 2003-01-13, under 510(k) number K023449.

Who is the listed applicant for NON-INVASIVE PATIENT FIXATION 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 NON-INVASIVE PATIENT FIXATION SYSTEM?

The FDA product code for NON-INVASIVE PATIENT FIXATION SYSTEM is IYE.

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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 MODULEK013775TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM

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Related Devices (Code: IYE)

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K261865AerFrame™ Alignment Laser Box (LBV2)Stabilix, LLCK261718EZFluence (RADEZ V2)Radformation, Inc.K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd.K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SAK253004LUNA 3DLap GmbH Laser Applikationen

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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