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FDA 510(k)

RMS K-WIRE

K-Number: K963367 · 1996-10-30

ApplicantRms Div.
Decision Date1996-10-30
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RMS K-WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Rms Div.. It received FDA 510(k) clearance on 1996-10-30 under 510(k) number K963367. 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 RMS K-WIRE?

RMS K-WIRE is a medical device that received FDA 510(k) clearance on 1996-10-30. The listed applicant is Rms Div.. The 510(k) number is K963367.

When did RMS K-WIRE receive FDA 510(k) clearance?

RMS K-WIRE received FDA 510(k) clearance on 1996-10-30, under 510(k) number K963367.

Who is the listed applicant for RMS K-WIRE?

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

What is the FDA product code for RMS K-WIRE?

The FDA product code for RMS K-WIRE is HTY.

Other records listing Rms Div. 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.

K954438SUNMED'S GREENLINE FIBER OPTIC LARYNGOSCOPEK944848THE VIVACARE T.P.S. PROBEK944557DW250 #91K941625DW234 #29K902403ELITE R/F SPOT FILM DRIVEK902146SFD-035 SPOT FILM DEVICE

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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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