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FDA 510(k)

BONE FIXATION WIRE (KIRSCHNER WIRE)

K-Number: K073674 · 2008-03-24

ApplicantSignal Medical Corp.
Decision Date2008-03-24
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BONE FIXATION WIRE (KIRSCHNER WIRE) 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 2008-03-24 under 510(k) number K073674. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONE FIXATION WIRE (KIRSCHNER WIRE)?

BONE FIXATION WIRE (KIRSCHNER WIRE) is a medical device that received FDA 510(k) clearance on 2008-03-24. The listed applicant is Signal Medical Corp.. The 510(k) number is K073674.

When did BONE FIXATION WIRE (KIRSCHNER WIRE) receive FDA 510(k) clearance?

BONE FIXATION WIRE (KIRSCHNER WIRE) received FDA 510(k) clearance on 2008-03-24, under 510(k) number K073674.

Who is the listed applicant for BONE FIXATION WIRE (KIRSCHNER WIRE)?

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 BONE FIXATION WIRE (KIRSCHNER WIRE)?

The FDA product code for BONE FIXATION WIRE (KIRSCHNER WIRE) is HTY.

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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 AGUMENTSK051510SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEMK043289E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOTK022382RHS ACETABULAR COMPONENTK021063GREAT TOE IMPLANTK981302SMC 28MM CERAMIC FEMORAL HEADS

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Related Devices (Code: HTY)

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.

K262722Primal K-Wire (P99-193-1410)Paragon 28, Inc.K253325ZipToe™ Hammertoe Fusion SystemToetal SolutionsK252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc.K250315RONAVIS – FX (FX-001)AIRS, Inc.K251362PediFlex™ Flexible Nail SystemOrthoPediatrics Corp.K250646Impact PEEK Union Nail SystemNvision Biomedical Technologies

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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