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FDA 510(k)

RECONSTRUCTION PLATE SYSTEM

K-Number: K924085 · 1992-12-17

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

Device Summary

RECONSTRUCTION PLATE 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 K924085. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the RECONSTRUCTION PLATE SYSTEM?

RECONSTRUCTION PLATE 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 K924085.

When did RECONSTRUCTION PLATE SYSTEM receive FDA 510(k) clearance?

RECONSTRUCTION PLATE SYSTEM received FDA 510(k) clearance on 1992-12-17, under 510(k) number K924085.

Who is the listed applicant for RECONSTRUCTION PLATE 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 RECONSTRUCTION PLATE SYSTEM?

The FDA product code for RECONSTRUCTION PLATE SYSTEM is HRS.

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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: HRS)

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.

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical TechnologiesK262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace SurgicalK261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim SirketiK262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

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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