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FDA 510(k)

STERILE STORM (R) OPERATING KIT

K-Number: K111001 · 2011-05-17

ApplicantIntelligent Orthopaedics, Ltd.
Decision Date2011-05-17
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STERILE STORM (R) OPERATING KIT is the device name listed in this FDA 510(k) record. The listed applicant is Intelligent Orthopaedics, Ltd.. It received FDA 510(k) clearance on 2011-05-17 under 510(k) number K111001. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE STORM (R) OPERATING KIT?

STERILE STORM (R) OPERATING KIT is a medical device that received FDA 510(k) clearance on 2011-05-17. The listed applicant is Intelligent Orthopaedics, Ltd.. The 510(k) number is K111001.

When did STERILE STORM (R) OPERATING KIT receive FDA 510(k) clearance?

STERILE STORM (R) OPERATING KIT received FDA 510(k) clearance on 2011-05-17, under 510(k) number K111001.

Who is the listed applicant for STERILE STORM (R) OPERATING KIT?

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

What is the FDA product code for STERILE STORM (R) OPERATING KIT?

The FDA product code for STERILE STORM (R) OPERATING KIT is HWC. This falls under the Cardiovascular category.

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Other records listing Intelligent Orthopaedics, Ltd. 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.

K070724IOS EXTERNAL FIXATOR, MODEL 2-0-0K061607STORM OPERATING KIT, MODEL 1-10-0

Related Devices (Code: HWC)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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