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FDA 510(k)

SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM

K-Number: K131980 · 2013-09-04

ApplicantZimmer Spine, Inc.
Decision Date2013-09-04
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Spine, Inc.. It received FDA 510(k) clearance on 2013-09-04 under 510(k) number K131980. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM?

SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM is a medical device that received FDA 510(k) clearance on 2013-09-04. The listed applicant is Zimmer Spine, Inc.. The 510(k) number is K131980.

When did SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM receive FDA 510(k) clearance?

SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM received FDA 510(k) clearance on 2013-09-04, under 510(k) number K131980.

Who is the listed applicant for SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM?

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

What is the FDA product code for SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM?

The FDA product code for SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM is NKB.

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Other records listing Zimmer Spine, Inc. as applicant

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Related Devices (Code: NKB)

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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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