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FDA 510(k)

GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.

K-Number: K153716 · 2016-05-17

ApplicantGpc Medical, Ltd.
Decision Date2016-05-17
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. is a medical device manufactured by Gpc Medical, Ltd.. It received FDA 510(k) clearance on 2016-05-17 under approval number K153716. 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 GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.?

GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. is a medical device that received FDA 510(k) clearance on 2016-05-17. It is manufactured by Gpc Medical, Ltd.. The 510(k) number is K153716.

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

GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. received FDA 510(k) clearance on 2016-05-17, under approval number K153716.

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

GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. is manufactured by Gpc Medical, Ltd..

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

The FDA product code for GPC 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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