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FDA 510(k)

MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING SYSTEM

K-Number: K101696 · 2010-09-10

ApplicantZimmer, Inc.
Decision Date2010-09-10
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING 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 2010-09-10 under 510(k) number K101696. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING SYSTEM?

MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING SYSTEM is a medical device that received FDA 510(k) clearance on 2010-09-10. The listed applicant is Zimmer, Inc.. The 510(k) number is K101696.

When did MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING SYSTEM receive FDA 510(k) clearance?

MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING SYSTEM received FDA 510(k) clearance on 2010-09-10, under 510(k) number K101696.

Who is the listed applicant for MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING 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 MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING SYSTEM?

The FDA product code for MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING SYSTEM is HWC. This falls under the Cardiovascular category.

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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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