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FDA 510(k)

LOCKING COMPRESSION PLATE

K-Number: K101400 · 2010-11-09

ApplicantChangzhou Orthmed Medical Instrument Co., Ltd.
Decision Date2010-11-09
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LOCKING COMPRESSION PLATE 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 2010-11-09 under 510(k) number K101400. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOCKING COMPRESSION PLATE?

LOCKING COMPRESSION PLATE is a medical device that received FDA 510(k) clearance on 2010-11-09. The listed applicant is Changzhou Orthmed Medical Instrument Co., Ltd.. The 510(k) number is K101400.

When did LOCKING COMPRESSION PLATE receive FDA 510(k) clearance?

LOCKING COMPRESSION PLATE received FDA 510(k) clearance on 2010-11-09, under 510(k) number K101400.

Who is the listed applicant for LOCKING COMPRESSION PLATE?

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 LOCKING COMPRESSION PLATE?

The FDA product code for LOCKING COMPRESSION PLATE is HRS.

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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.

K111690DEVINE SPINAL SYSTEM

Related Devices (Code: HRS)

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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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