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FDA 510(k)

SPINAL CONCEPTS, INC., BACFIX TI SPINAL FIXATION SYSTEM

K-Number: K973687 · 1998-03-18

ApplicantSpinal Concepts, Inc.
Decision Date1998-03-18
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

SPINAL CONCEPTS, INC., BACFIX TI 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 1998-03-18 under 510(k) number K973687. 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 for Some Indications.

Frequently Asked Questions

What is the SPINAL CONCEPTS, INC., BACFIX TI SPINAL FIXATION SYSTEM?

SPINAL CONCEPTS, INC., BACFIX TI SPINAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 1998-03-18. The listed applicant is Spinal Concepts, Inc.. The 510(k) number is K973687.

When did SPINAL CONCEPTS, INC., BACFIX TI SPINAL FIXATION SYSTEM receive FDA 510(k) clearance?

SPINAL CONCEPTS, INC., BACFIX TI SPINAL FIXATION SYSTEM received FDA 510(k) clearance on 1998-03-18, under 510(k) number K973687.

Who is the listed applicant for SPINAL CONCEPTS, INC., BACFIX TI 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 SPINAL CONCEPTS, INC., BACFIX TI SPINAL FIXATION SYSTEM?

The FDA product code for SPINAL CONCEPTS, INC., BACFIX TI 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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