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FDA 510(k)

KINAMED PROFIX SYSTEM

K-Number: K964362 · 1997-01-16

ApplicantKinamed, Inc.
Decision Date1997-01-16
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KINAMED PROFIX SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Kinamed, Inc.. It received FDA 510(k) clearance on 1997-01-16 under 510(k) number K964362. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KINAMED PROFIX SYSTEM?

KINAMED PROFIX SYSTEM is a medical device that received FDA 510(k) clearance on 1997-01-16. The listed applicant is Kinamed, Inc.. The 510(k) number is K964362.

When did KINAMED PROFIX SYSTEM receive FDA 510(k) clearance?

KINAMED PROFIX SYSTEM received FDA 510(k) clearance on 1997-01-16, under 510(k) number K964362.

Who is the listed applicant for KINAMED PROFIX SYSTEM?

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

What is the FDA product code for KINAMED PROFIX SYSTEM?

The FDA product code for KINAMED PROFIX SYSTEM is HRS.

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Other records listing Kinamed, 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.

K122049NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEMK072250SUPERCABLE GRIP AND PLATE SYSTEMK050897NAVIPRO SHOULDER SOFTWARE MODULEK033668NAVIPRO KNEE SOFTWARE MODULEK032950GEM INSET PATELLAR COMPONENTK030256ISO-ELASTIC CERCLAGE 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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