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FDA 510(k)

FIXATION WIRE

K-Number: K911505 · 1991-04-12

ApplicantSimpex, Inc.
Decision Date1991-04-12
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FIXATION WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Simpex, Inc.. It received FDA 510(k) clearance on 1991-04-12 under 510(k) number K911505. 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 FIXATION WIRE?

FIXATION WIRE is a medical device that received FDA 510(k) clearance on 1991-04-12. The listed applicant is Simpex, Inc.. The 510(k) number is K911505.

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

FIXATION WIRE received FDA 510(k) clearance on 1991-04-12, under 510(k) number K911505.

Who is the listed applicant for FIXATION WIRE?

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

What is the FDA product code for FIXATION WIRE?

The FDA product code for FIXATION WIRE is HTY.

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 Simpex, 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.

K920174EASY TOUCH LATEX EAM GLOVESK913793SIMPEX INC. ORAL AND RECTAL THERMOMETERSK913794SIMPEX INC. SURGICAL DRESSINGK911452FIXATION PIN

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

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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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