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FDA 510(k)

ODALYS PEDICLE SCREW SYSTEM

K-Number: K111370 · 2011-09-21

ApplicantKalitec Direct, LLC
Decision Date2011-09-21
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ODALYS PEDICLE SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Kalitec Direct, LLC. It received FDA 510(k) clearance on 2011-09-21 under 510(k) number K111370. 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 ODALYS PEDICLE SCREW SYSTEM?

ODALYS PEDICLE SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2011-09-21. The listed applicant is Kalitec Direct, LLC. The 510(k) number is K111370.

When did ODALYS PEDICLE SCREW SYSTEM receive FDA 510(k) clearance?

ODALYS PEDICLE SCREW SYSTEM received FDA 510(k) clearance on 2011-09-21, under 510(k) number K111370.

Who is the listed applicant for ODALYS PEDICLE SCREW SYSTEM?

The FDA 510(k) record lists Kalitec Direct, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ODALYS PEDICLE SCREW SYSTEM?

The FDA product code for ODALYS PEDICLE SCREW SYSTEM is MNH. This falls under the ENT category.

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Other records listing Kalitec Direct, LLC 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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