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FDA 510(k)

OPTIMA SPINAL SYSTEM

K-Number: K051971 · 2005-08-04

ApplicantU&I Corp.
Decision Date2005-08-04
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OPTIMA SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is U&I Corp.. It received FDA 510(k) clearance on 2005-08-04 under 510(k) number K051971. 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 OPTIMA SPINAL SYSTEM?

OPTIMA SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2005-08-04. The listed applicant is U&I Corp.. The 510(k) number is K051971.

When did OPTIMA SPINAL SYSTEM receive FDA 510(k) clearance?

OPTIMA SPINAL SYSTEM received FDA 510(k) clearance on 2005-08-04, under 510(k) number K051971.

Who is the listed applicant for OPTIMA SPINAL SYSTEM?

The FDA 510(k) record lists U&I Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTIMA SPINAL SYSTEM?

The FDA product code for OPTIMA SPINAL SYSTEM is KWQ.

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Other records listing U&I Corp. 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.

K120419DYNA LOCKING ANKLE NAILK112240DYNA LOCKING CANNULATED SCREWK102367OPTIGEN TOTAL KNEE SYSTEMK093707DYNA LOCKING TROCHANTERIC NAIL, MODEL NG0820K092771DYNA LOCKING IM NAILK091725PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549)

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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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