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FDA 510(k)

SPINE-TECH LAPAROSCOPIC INSTRUMENTATION SYSTEM

K-Number: K940913 · 1994-10-04

ApplicantSpine-Tech, Inc.
Decision Date1994-10-04
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPINE-TECH LAPAROSCOPIC INSTRUMENTATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spine-Tech, Inc.. It received FDA 510(k) clearance on 1994-10-04 under 510(k) number K940913. 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 SPINE-TECH LAPAROSCOPIC INSTRUMENTATION SYSTEM?

SPINE-TECH LAPAROSCOPIC INSTRUMENTATION SYSTEM is a medical device that received FDA 510(k) clearance on 1994-10-04. The listed applicant is Spine-Tech, Inc.. The 510(k) number is K940913.

When did SPINE-TECH LAPAROSCOPIC INSTRUMENTATION SYSTEM receive FDA 510(k) clearance?

SPINE-TECH LAPAROSCOPIC INSTRUMENTATION SYSTEM received FDA 510(k) clearance on 1994-10-04, under 510(k) number K940913.

Who is the listed applicant for SPINE-TECH LAPAROSCOPIC INSTRUMENTATION SYSTEM?

The FDA 510(k) record lists Spine-Tech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPINE-TECH LAPAROSCOPIC INSTRUMENTATION SYSTEM?

The FDA product code for SPINE-TECH LAPAROSCOPIC INSTRUMENTATION 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 Spine-Tech, 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.

K980288SPINE-TECH SILHOUETTE SPINAL FIXATION SYSTEMK970040SPINE-TECH BONE HARVESTERK951268SPINE-TECH MODIFIED LAPAROSCOPIC SPINAL FUSION INSTRUMENT SYSTEM

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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