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FDA 510(k)

BRYAN POSTERIOR SPINAL FIXATOR (BPSF)

K-Number: K953416 · 1995-10-03

ApplicantArcan Orthopaedic Corp.
Decision Date1995-10-03
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

BRYAN POSTERIOR SPINAL FIXATOR (BPSF) is the device name listed in this FDA 510(k) record. The listed applicant is Arcan Orthopaedic Corp.. It received FDA 510(k) clearance on 1995-10-03 under 510(k) number K953416. 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 BRYAN POSTERIOR SPINAL FIXATOR (BPSF)?

BRYAN POSTERIOR SPINAL FIXATOR (BPSF) is a medical device that received FDA 510(k) clearance on 1995-10-03. The listed applicant is Arcan Orthopaedic Corp.. The 510(k) number is K953416.

When did BRYAN POSTERIOR SPINAL FIXATOR (BPSF) receive FDA 510(k) clearance?

BRYAN POSTERIOR SPINAL FIXATOR (BPSF) received FDA 510(k) clearance on 1995-10-03, under 510(k) number K953416.

Who is the listed applicant for BRYAN POSTERIOR SPINAL FIXATOR (BPSF)?

The FDA 510(k) record lists Arcan Orthopaedic Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BRYAN POSTERIOR SPINAL FIXATOR (BPSF)?

The FDA product code for BRYAN POSTERIOR SPINAL FIXATOR (BPSF) is MNH. This falls under the ENT category.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Arcan Orthopaedic Corp. 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.

K971457BRYAN POSTERIOR SPINAL FIXATOR (BPSF), MODIFIEDK955927BRYAN POSTERIOR SPINAL FIXATOR (MODIFICATION)K945435BRYAN POSTERIOR SPINAL FIXATOR (BPSF)K914548BRYAN SPINAL FIXATER (BSF)

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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