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FDA 510(k)

KMI WRIST FUSION SYSTEM

K-Number: K990094 · 1999-02-18

ApplicantKinetikos Medical, Inc.
Decision Date1999-02-18
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KMI WRIST FUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Kinetikos Medical, Inc.. It received FDA 510(k) clearance on 1999-02-18 under 510(k) number K990094. 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 KMI WRIST FUSION SYSTEM?

KMI WRIST FUSION SYSTEM is a medical device that received FDA 510(k) clearance on 1999-02-18. The listed applicant is Kinetikos Medical, Inc.. The 510(k) number is K990094.

When did KMI WRIST FUSION SYSTEM receive FDA 510(k) clearance?

KMI WRIST FUSION SYSTEM received FDA 510(k) clearance on 1999-02-18, under 510(k) number K990094.

Who is the listed applicant for KMI WRIST FUSION SYSTEM?

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

What is the FDA product code for KMI WRIST FUSION SYSTEM?

The FDA product code for KMI WRIST FUSION SYSTEM is HRS.

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Other records listing Kinetikos Medical, Inc. as applicant

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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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