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FDA 510(k)

STERILE DYNA LOK ANTERIOR PLATING SYSTEM

K-Number: K923446 · 1992-12-17

ApplicantSofamor Danek Mfg., Inc.
Decision Date1992-12-17
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

STERILE DYNA LOK ANTERIOR PLATING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sofamor Danek Mfg., Inc.. It received FDA 510(k) clearance on 1992-12-17 under 510(k) number K923446. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the STERILE DYNA LOK ANTERIOR PLATING SYSTEM?

STERILE DYNA LOK ANTERIOR PLATING SYSTEM is a medical device that received FDA 510(k) clearance on 1992-12-17. The listed applicant is Sofamor Danek Mfg., Inc.. The 510(k) number is K923446.

When did STERILE DYNA LOK ANTERIOR PLATING SYSTEM receive FDA 510(k) clearance?

STERILE DYNA LOK ANTERIOR PLATING SYSTEM received FDA 510(k) clearance on 1992-12-17, under 510(k) number K923446.

Who is the listed applicant for STERILE DYNA LOK ANTERIOR PLATING SYSTEM?

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

What is the FDA product code for STERILE DYNA LOK ANTERIOR PLATING SYSTEM?

The FDA product code for STERILE DYNA LOK ANTERIOR PLATING SYSTEM is KWQ.

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Other records listing Sofamor Danek Mfg., Inc. 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.

K936294SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMSK930191DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SYK932029TSRH SPINAL SCREWSK922486DANEK TISSUE CUTTING AND REMOVAL SYSTEMK930807SENTRY ANTERIOR SPINAL SYSTEMK930710SENTRY POSTERIOR SPINAL 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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