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FDA 510(k)

CATALYST

K-Number: K113276 · 2012-02-27

ApplicantC-Rad Positioning AB
Decision Date2012-02-27
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CATALYST is the device name listed in this FDA 510(k) record. The listed applicant is C-Rad Positioning AB. It received FDA 510(k) clearance on 2012-02-27 under 510(k) number K113276. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATALYST?

CATALYST is a medical device that received FDA 510(k) clearance on 2012-02-27. The listed applicant is C-Rad Positioning AB. The 510(k) number is K113276.

When did CATALYST receive FDA 510(k) clearance?

CATALYST received FDA 510(k) clearance on 2012-02-27, under 510(k) number K113276.

Who is the listed applicant for CATALYST?

The FDA 510(k) record lists C-Rad Positioning AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CATALYST?

The FDA product code for CATALYST is IYE.

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Related PubMed Literature

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.

PMID: 32224627Three-Dimensional Printing: A Catalyst for a Changing Orthopaedic Landscape.JBJS reviews ()

Other records listing C-Rad Positioning AB 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.

K200435Catalyst+, Catalyst+ HDK200600SentinelK120668SENTINELK082582SENTINEL, MODEL SP-001K063839POSITIONER

Related Devices (Code: IYE)

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.

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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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