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FDA 510(k)

MASS (MICRO-ACCESS SPINE SYSTEM)

K-Number: K992583 · 1999-10-29

ApplicantOmni-Tract Surgical, Div. Minn. Scientific, Inc.
Decision Date1999-10-29
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MASS (MICRO-ACCESS SPINE SYSTEM) is the device name listed in this FDA 510(k) record. The listed applicant is Omni-Tract Surgical, Div. Minn. Scientific, Inc.. It received FDA 510(k) clearance on 1999-10-29 under 510(k) number K992583. 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 MASS (MICRO-ACCESS SPINE SYSTEM)?

MASS (MICRO-ACCESS SPINE SYSTEM) is a medical device that received FDA 510(k) clearance on 1999-10-29. The listed applicant is Omni-Tract Surgical, Div. Minn. Scientific, Inc.. The 510(k) number is K992583.

When did MASS (MICRO-ACCESS SPINE SYSTEM) receive FDA 510(k) clearance?

MASS (MICRO-ACCESS SPINE SYSTEM) received FDA 510(k) clearance on 1999-10-29, under 510(k) number K992583.

Who is the listed applicant for MASS (MICRO-ACCESS SPINE SYSTEM)?

The FDA 510(k) record lists Omni-Tract Surgical, Div. Minn. Scientific, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MASS (MICRO-ACCESS SPINE SYSTEM)?

The FDA product code for MASS (MICRO-ACCESS SPINE SYSTEM) is HRX.

Related Clinical Trials

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.

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Other records listing Omni-Tract Surgical, Div. Minn. Scientific, 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.

K001339MRI FASTSYSTEM RETRACTOR SYSTEMK950214ABDOMINAL WALL RETRACTORK913803INTRALUMINAL ARTERY STRIPPER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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