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FDA 510(k)

BACFIX SPINAL FIXATION SYSTEM

K-Number: K013887 · 2002-02-12

ApplicantSpinal Concepts, Inc.
Decision Date2002-02-12
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BACFIX SPINAL FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Concepts, Inc.. It received FDA 510(k) clearance on 2002-02-12 under 510(k) number K013887. 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 BACFIX SPINAL FIXATION SYSTEM?

BACFIX SPINAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2002-02-12. The listed applicant is Spinal Concepts, Inc.. The 510(k) number is K013887.

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

BACFIX SPINAL FIXATION SYSTEM received FDA 510(k) clearance on 2002-02-12, under 510(k) number K013887.

Who is the listed applicant for BACFIX SPINAL FIXATION SYSTEM?

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

What is the FDA product code for BACFIX SPINAL FIXATION SYSTEM?

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

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Other records listing Spinal Concepts, 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.

K051000FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICEK050706HARMONY PORT SYSTEM, MODEL 1907 SERIESK040096SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEMK033663SPINAL CONCEPTS INC. CODAK033517SPINAL CONCEPTS INC. CADENCE AND TRAXISK031855SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW 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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