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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 a medical device manufactured by Hospital Equipment Manufacturing Company. It received FDA 510(k) clearance on 2022-10-27 under approval 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. It is manufactured by Hospital Equipment Manufacturing Company. The 510(k) number is K222282.

When was HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System approved by the FDA?

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

What company makes HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System?

HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System is manufactured by Hospital Equipment Manufacturing Company.

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

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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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