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FDA 510(k)

E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT

K-Number: K043289 · 2005-02-11

ApplicantSignal Medical Corp.
Decision Date2005-02-11
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT is the device name listed in this FDA 510(k) record. The listed applicant is Signal Medical Corp.. It received FDA 510(k) clearance on 2005-02-11 under 510(k) number K043289. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT?

E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT is a medical device that received FDA 510(k) clearance on 2005-02-11. The listed applicant is Signal Medical Corp.. The 510(k) number is K043289.

When did E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT receive FDA 510(k) clearance?

E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT received FDA 510(k) clearance on 2005-02-11, under 510(k) number K043289.

Who is the listed applicant for E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT?

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

What is the FDA product code for E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT?

The FDA product code for E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT is KTT.

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Other records listing Signal Medical Corp. 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.

K100370SYMMETRIC TOTAL KNEE AGUMENTSK073674BONE FIXATION WIRE (KIRSCHNER WIRE)K051510SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEMK022382RHS ACETABULAR COMPONENTK021063GREAT TOE IMPLANTK981302SMC 28MM CERAMIC FEMORAL HEADS

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Related Devices (Code: KTT)

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.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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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