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FDA 510(k)

METRX SYSTEM

K-Number: K993021 · 1999-11-10

ApplicantSurgical Navigation Technologies, Inc.
Decision Date1999-11-10
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

METRX SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Navigation Technologies, Inc.. It received FDA 510(k) clearance on 1999-11-10 under 510(k) number K993021. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the METRX SYSTEM?

METRX SYSTEM is a medical device that received FDA 510(k) clearance on 1999-11-10. The listed applicant is Surgical Navigation Technologies, Inc.. The 510(k) number is K993021.

When did METRX SYSTEM receive FDA 510(k) clearance?

METRX SYSTEM received FDA 510(k) clearance on 1999-11-10, under 510(k) number K993021.

Who is the listed applicant for METRX SYSTEM?

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

What is the FDA product code for METRX SYSTEM?

The FDA product code for METRX SYSTEM is HRX.

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Other records listing Surgical Navigation Technologies, Inc. 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.

K000246RADIOCAMERAS EXTRACRANIAL SYSTEMK994355RADIOCAMERAS SYSTEM HEAD/NECK APPLICATIONK992461STEALTHSTATION TREATMENT GUIDANCE PLATFORMK992927STEALTHSTATION TREATMENT GUIDANCE PLATFORMK992354SNT IMAGE ANALYSIS SYSTEMK991468IMMERGE IMAGE CORRELATION

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Related Devices (Code: HRX)

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.

K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KGK252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)

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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