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FDA 510(k)

GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate Plating System

K-Number: K163383 · 2017-04-19

ApplicantGreens Surgicals Pvt. , Ltd.
Decision Date2017-04-19
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Greens Surgicals Pvt. , Ltd.. It received FDA 510(k) clearance on 2017-04-19 under 510(k) number K163383. 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 GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate Plating System?

GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate Plating System is a medical device that received FDA 510(k) clearance on 2017-04-19. The listed applicant is Greens Surgicals Pvt. , Ltd.. The 510(k) number is K163383.

When did GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate Plating System receive FDA 510(k) clearance?

GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate Plating System received FDA 510(k) clearance on 2017-04-19, under 510(k) number K163383.

Who is the listed applicant for GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate Plating System?

The FDA 510(k) record lists Greens Surgicals Pvt. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate Plating System?

The FDA product code for GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate 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_RECRUITINGNCT07645768Is Anterior Reversed Proximal Humeral Locking Plate System (PHILOS) a Safe Alternative to Conventional Posterior Double Plating in Extra-Articular Distal Shaft Humeral FracturesACTIVE_NOT_RECRUITINGNCT07693933Biodegradable Magnesium Screws for Unstable Ankle Fracture SurgeryNOT_YET_RECRUITINGNCT07736430Evaluation of Pin Buckle Bone Plates for Management of Anterior Mandibular FracturesCOMPLETEDNCT07774091Clinical Outcomes After Treatment of Distal Humerus Fractures With the LORRAINE 2.5/3.5 mm Distal Humerus SystemNOT_YET_RECRUITING

Other records listing Greens Surgicals Pvt. , 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.

K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System

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

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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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