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FDA 510(k)

KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS

K-Number: K950999 · 1996-01-25

ApplicantBuckman Co., Inc.
Decision Date1996-01-25
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Buckman Co., Inc.. It received FDA 510(k) clearance on 1996-01-25 under 510(k) number K950999. 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 KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS?

KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS is a medical device that received FDA 510(k) clearance on 1996-01-25. The listed applicant is Buckman Co., Inc.. The 510(k) number is K950999.

When did KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS receive FDA 510(k) clearance?

KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS received FDA 510(k) clearance on 1996-01-25, under 510(k) number K950999.

Who is the listed applicant for KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS?

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

What is the FDA product code for KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS?

The FDA product code for KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS is MNH. This falls under the ENT category.

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Other records listing Buckman Co., 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.

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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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