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FDA 510(k)

Cable-Ready Cable Grip System: Cable-Ready Bone Plate System

K-Number: K151716 · 2016-01-28

ApplicantZimmer, Inc.
Decision Date2016-01-28
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cable-Ready Cable Grip System: Cable-Ready Bone Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2016-01-28 under 510(k) number K151716. 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 Cable-Ready Cable Grip System: Cable-Ready Bone Plate System?

Cable-Ready Cable Grip System: Cable-Ready Bone Plate System is a medical device that received FDA 510(k) clearance on 2016-01-28. The listed applicant is Zimmer, Inc.. The 510(k) number is K151716.

When did Cable-Ready Cable Grip System: Cable-Ready Bone Plate System receive FDA 510(k) clearance?

Cable-Ready Cable Grip System: Cable-Ready Bone Plate System received FDA 510(k) clearance on 2016-01-28, under 510(k) number K151716.

Who is the listed applicant for Cable-Ready Cable Grip System: Cable-Ready Bone Plate System?

The FDA 510(k) record lists Zimmer, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cable-Ready Cable Grip System: Cable-Ready Bone Plate System?

The FDA product code for Cable-Ready Cable Grip System: Cable-Ready Bone Plate System is HRS.

Other records listing Zimmer, Inc. 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.

PMA P060037Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearingK261683Augment Off-Axis Instrument SystemK260831Z1 Hip SystemK251840Zimmer® Persona® Personalized Knee SystemK260182Avenir® Müller Stem; Avenir Complete™ Hip SystemK253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)

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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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