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FDA 510(k)

SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM

K-Number: K950099 · 1997-01-16

ApplicantBuckman Co., Inc.
Decision Date1997-01-16
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM 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 1997-01-16 under 510(k) number K950099. 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 SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM?

SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 1997-01-16. The listed applicant is Buckman Co., Inc.. The 510(k) number is K950099.

When did SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM receive FDA 510(k) clearance?

SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM received FDA 510(k) clearance on 1997-01-16, under 510(k) number K950099.

Who is the listed applicant for SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM?

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 SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM?

The FDA product code for SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM 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.

K961320CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEMK974641FUTURELASE 3000/3002 ERBIUM LASER SYSTEMK964252ORTHOCHUCKK960451WEBB-MORLEY SPINE SYSTEMK950999KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESISK945756IMAGN(TM) 2000 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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