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FDA 510(k)

ORTHODONTIC NITINOL SPRINGS

K-Number: K881331 · 1988-04-21

ApplicantFlexmedics
Decision Date1988-04-21
Product CodeEJW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHODONTIC NITINOL SPRINGS is the device name listed in this FDA 510(k) record. The listed applicant is Flexmedics. It received FDA 510(k) clearance on 1988-04-21 under 510(k) number K881331. The device is classified under product code EJW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHODONTIC NITINOL SPRINGS?

ORTHODONTIC NITINOL SPRINGS is a medical device that received FDA 510(k) clearance on 1988-04-21. The listed applicant is Flexmedics. The 510(k) number is K881331.

When did ORTHODONTIC NITINOL SPRINGS receive FDA 510(k) clearance?

ORTHODONTIC NITINOL SPRINGS received FDA 510(k) clearance on 1988-04-21, under 510(k) number K881331.

Who is the listed applicant for ORTHODONTIC NITINOL SPRINGS?

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 ORTHODONTIC NITINOL SPRINGS?

The FDA product code for ORTHODONTIC NITINOL SPRINGS is EJW.

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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

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Related Devices (Code: EJW)

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.

K901257WIRONTOM CLASP WIREIvoclar North America, Inc.K872746VITALLIUM WIREAustenal Dental, 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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