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FDA 510(k)

MODIFICATION TO ISOBAR SPINAL SYSTEM

K-Number: K000020 · 2000-02-03

ApplicantEncore Orthopedics, Inc.
Decision Date2000-02-03
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ISOBAR SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Encore Orthopedics, Inc.. It received FDA 510(k) clearance on 2000-02-03 under 510(k) number K000020. 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 MODIFICATION TO ISOBAR SPINAL SYSTEM?

MODIFICATION TO ISOBAR SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2000-02-03. The listed applicant is Encore Orthopedics, Inc.. The 510(k) number is K000020.

When did MODIFICATION TO ISOBAR SPINAL SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO ISOBAR SPINAL SYSTEM received FDA 510(k) clearance on 2000-02-03, under 510(k) number K000020.

Who is the listed applicant for MODIFICATION TO ISOBAR SPINAL SYSTEM?

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

What is the FDA product code for MODIFICATION TO ISOBAR SPINAL SYSTEM?

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

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Other records listing Encore Orthopedics, Inc. as applicant

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Related Devices (Code: MNH)

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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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