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FDA 510(k)

MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM

K-Number: K012305 · 2001-08-22

ApplicantSulzer Spine-Tech
Decision Date2001-08-22
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sulzer Spine-Tech. It received FDA 510(k) clearance on 2001-08-22 under 510(k) number K012305. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM?

MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2001-08-22. The listed applicant is Sulzer Spine-Tech. The 510(k) number is K012305.

When did MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM received FDA 510(k) clearance on 2001-08-22, under 510(k) number K012305.

Who is the listed applicant for MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM?

The FDA 510(k) record lists Sulzer Spine-Tech as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM?

The FDA product code for MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM is KWQ.

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Other records listing Sulzer Spine-Tech 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.

K022374CADENCE SPINAL FIXATION SYSTEMK020344RPX TITANIUM CEMNT RESTRICTORK020196MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEMK012173DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEMK993067SILHOUETTE SPINAL FIXATION SYSTEMK992276MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM

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Related Devices (Code: KWQ)

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.

K262149corra® cervical plating systemCarlsmed, Inc.K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC

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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