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FDA 510(k)

INTELIFUSE, INC. WARM SYSTEM WITH STIMULINKS

K-Number: K051408 · 2005-06-29

ApplicantIntelifuse, Inc.
Decision Date2005-06-29
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INTELIFUSE, INC. WARM SYSTEM WITH STIMULINKS is the device name listed in this FDA 510(k) record. The listed applicant is Intelifuse, Inc.. It received FDA 510(k) clearance on 2005-06-29 under 510(k) number K051408. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTELIFUSE, INC. WARM SYSTEM WITH STIMULINKS?

INTELIFUSE, INC. WARM SYSTEM WITH STIMULINKS is a medical device that received FDA 510(k) clearance on 2005-06-29. The listed applicant is Intelifuse, Inc.. The 510(k) number is K051408.

When did INTELIFUSE, INC. WARM SYSTEM WITH STIMULINKS receive FDA 510(k) clearance?

INTELIFUSE, INC. WARM SYSTEM WITH STIMULINKS received FDA 510(k) clearance on 2005-06-29, under 510(k) number K051408.

Who is the listed applicant for INTELIFUSE, INC. WARM SYSTEM WITH STIMULINKS?

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

What is the FDA product code for INTELIFUSE, INC. WARM SYSTEM WITH STIMULINKS?

The FDA product code for INTELIFUSE, INC. WARM SYSTEM WITH STIMULINKS is JDR.

Related Clinical Trials

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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Other records listing Intelifuse, 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.

K060014INTELIFUSE, INC., WARMSYSTEM WITH STIMULINKS

Related Devices (Code: JDR)

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.

K262451Arthrex DynaNite StaplesArthrex, Inc.K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical Concepts

Official Source

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