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FDA 510(k)

TRABECULAR METAL (TM) FUSION DEVICE

K-Number: K111119 · 2011-11-23

ApplicantZimmer Spine, Inc.
Decision Date2011-11-23
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRABECULAR METAL (TM) FUSION DEVICE 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 2011-11-23 under 510(k) number K111119. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRABECULAR METAL (TM) FUSION DEVICE?

TRABECULAR METAL (TM) FUSION DEVICE is a medical device that received FDA 510(k) clearance on 2011-11-23. The listed applicant is Zimmer Spine, Inc.. The 510(k) number is K111119.

When did TRABECULAR METAL (TM) FUSION DEVICE receive FDA 510(k) clearance?

TRABECULAR METAL (TM) FUSION DEVICE received FDA 510(k) clearance on 2011-11-23, under 510(k) number K111119.

Who is the listed applicant for TRABECULAR METAL (TM) FUSION DEVICE?

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 TRABECULAR METAL (TM) FUSION DEVICE?

The FDA product code for TRABECULAR METAL (TM) FUSION DEVICE is ODP.

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Other records listing Zimmer Spine, Inc. as applicant

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K153631Zimmer Virage OCT Spinal Fixation SystemK132790INFIX ANTERIOR LUMBAR SYSTEMK133291ST360 DEGREES SPINAL FIXATION SYSTEMK133086TITLE 2 POLYAXIAL SPINAL SYSTEMK132884PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEMK131980SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM

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Related Devices (Code: ODP)

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.

K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.

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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