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FDA 510(k)

DEVINE SPINAL SYSTEM

K-Number: K111690 · 2011-11-22

ApplicantChangzhou Orthmed Medical Instrument Co., Ltd.
Decision Date2011-11-22
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DEVINE SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Orthmed Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2011-11-22 under 510(k) number K111690. 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 DEVINE SPINAL SYSTEM?

DEVINE SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2011-11-22. The listed applicant is Changzhou Orthmed Medical Instrument Co., Ltd.. The 510(k) number is K111690.

When did DEVINE SPINAL SYSTEM receive FDA 510(k) clearance?

DEVINE SPINAL SYSTEM received FDA 510(k) clearance on 2011-11-22, under 510(k) number K111690.

Who is the listed applicant for DEVINE SPINAL SYSTEM?

The FDA 510(k) record lists Changzhou Orthmed Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEVINE SPINAL SYSTEM?

The FDA product code for DEVINE SPINAL SYSTEM 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 Changzhou Orthmed Medical Instrument Co., Ltd. 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.

K101400LOCKING COMPRESSION PLATE

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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