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FDA 510(k)

ISOLOCK SPINAL SYSTEM

K-Number: K990721 · 1999-05-27

ApplicantScien'Tx USA, Inc.
Decision Date1999-05-27
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ISOLOCK SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Scien'Tx USA, Inc.. It received FDA 510(k) clearance on 1999-05-27 under 510(k) number K990721. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISOLOCK SPINAL SYSTEM?

ISOLOCK SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 1999-05-27. The listed applicant is Scien'Tx USA, Inc.. The 510(k) number is K990721.

When did ISOLOCK SPINAL SYSTEM receive FDA 510(k) clearance?

ISOLOCK SPINAL SYSTEM received FDA 510(k) clearance on 1999-05-27, under 510(k) number K990721.

Who is the listed applicant for ISOLOCK SPINAL SYSTEM?

The FDA 510(k) record lists Scien'Tx USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISOLOCK SPINAL SYSTEM?

The FDA product code for ISOLOCK SPINAL SYSTEM is MNH. This falls under the ENT category.

Related Clinical Trials

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Other records listing Scien'Tx USA, 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.

K020245MODIFICATION TO ISOBAR SPINAL SYSTEMK013447ISOBAR SPINAL SYSTEMK013439ANTERIOR CERVICAL PLATE SYSTEMK013440ISOBAR SPINAL SYSTEMK013444ISOBAR SPINAL SYSTEMK991326ISOBAR SEMI-RIGID SPINAL SYSTEM

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Related Devices (Code: MNH)

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.

K162066Reliance Spinal Screw SystemReliance Medical Systems, LLCK162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.K162143FixxSure® X-LinkInnovasis, Inc.K161151Spinal fixation systemCanwell Medical Co., Ltd.K162189ANAX™ 5.5 Spinal SystemU&I CorporationK151362HC Spinal SystemHung Chun Bio-S Co., Ltd.

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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