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FDA 510(k)

FLEX PLASTIC PLASTIC COATED NITINOL ARCH WIRE

K-Number: K883120 · 1988-11-14

ApplicantFlexmedics
Decision Date1988-11-14
Product CodeEJF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FLEX PLASTIC PLASTIC COATED NITINOL ARCH WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Flexmedics. It received FDA 510(k) clearance on 1988-11-14 under 510(k) number K883120. The device is classified under product code EJF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEX PLASTIC PLASTIC COATED NITINOL ARCH WIRE?

FLEX PLASTIC PLASTIC COATED NITINOL ARCH WIRE is a medical device that received FDA 510(k) clearance on 1988-11-14. The listed applicant is Flexmedics. The 510(k) number is K883120.

When did FLEX PLASTIC PLASTIC COATED NITINOL ARCH WIRE receive FDA 510(k) clearance?

FLEX PLASTIC PLASTIC COATED NITINOL ARCH WIRE received FDA 510(k) clearance on 1988-11-14, under 510(k) number K883120.

Who is the listed applicant for FLEX PLASTIC PLASTIC COATED NITINOL ARCH WIRE?

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

What is the FDA product code for FLEX PLASTIC PLASTIC COATED NITINOL ARCH WIRE?

The FDA product code for FLEX PLASTIC PLASTIC COATED NITINOL ARCH WIRE is EJF.

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Other records listing Flexmedics 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.

K990765FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NOK964955FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKINGK952430FINESSE GUIDEWIRE CORONARYK943390FLEXFINDER GUIDEWIREK942074FLEXFINDER GUIDEWIREK934265FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE

View all 20 devices →

Related Devices (Code: EJF)

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.

K994357BITEM LOCK, MODELS SW006, SW012Thermoelastic Technologies, Inc.K932825MICROARCH GOLD BRACKETGac Intl., Inc.K933501ALASTIKUnitek Corp.K923372MEMORY WIREAlthan, Inc.K933080ORTHOTECH DURA-GOLD BARCKETSOrthotechK935139FASCINATION CERAMIC BRACKETDentauraum, Inc.

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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