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FDA 510(k)

DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM - PEDICLE FIXATION

K-Number: K950697 · 1995-06-22

ApplicantDepuy Motech
Decision Date1995-06-22
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM - PEDICLE FIXATION is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Motech. It received FDA 510(k) clearance on 1995-06-22 under 510(k) number K950697. 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 DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM - PEDICLE FIXATION?

DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM - PEDICLE FIXATION is a medical device that received FDA 510(k) clearance on 1995-06-22. The listed applicant is Depuy Motech. The 510(k) number is K950697.

When did DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM - PEDICLE FIXATION receive FDA 510(k) clearance?

DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM - PEDICLE FIXATION received FDA 510(k) clearance on 1995-06-22, under 510(k) number K950697.

Who is the listed applicant for DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM - PEDICLE FIXATION?

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

What is the FDA product code for DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM - PEDICLE FIXATION?

The FDA product code for DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM - PEDICLE FIXATION 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.

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Other records listing Depuy Motech 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.

K950695DEPUY MOTECH MOSS SPINAL SYSTEM - PEDICLE FIXATION

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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