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FDA 510(k)

HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System

K-Number: K222282 · 2022-10-27

ApplicantHospital Equipment Manufacturing Company
Decision Date2022-10-27
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Hospital Equipment Manufacturing Company. It received FDA 510(k) clearance on 2022-10-27 under 510(k) number K222282. 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 HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System?

HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System is a medical device that received FDA 510(k) clearance on 2022-10-27. The listed applicant is Hospital Equipment Manufacturing Company. The 510(k) number is K222282.

When did HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System receive FDA 510(k) clearance?

HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System received FDA 510(k) clearance on 2022-10-27, under 510(k) number K222282.

Who is the listed applicant for HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System?

The FDA 510(k) record lists Hospital Equipment Manufacturing Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System?

The FDA product code for HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System is HRS.

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.

NCT06938607Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain PlacementNOT_YET_RECRUITINGNCT07693933Biodegradable Magnesium Screws for Unstable Ankle Fracture SurgeryNOT_YET_RECRUITINGNCT07774091Clinical Outcomes After Treatment of Distal Humerus Fractures With the LORRAINE 2.5/3.5 mm Distal Humerus SystemNOT_YET_RECRUITING

Related Devices (Code: HRS)

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.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

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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