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FDA 510(k)

COLBALT ALLOY ORTHOPAEDIC WIRE

K-Number: K811500 · 1981-06-18

ApplicantOsteonics Corp.
Decision Date1981-06-18
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COLBALT ALLOY ORTHOPAEDIC WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1981-06-18 under 510(k) number K811500. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLBALT ALLOY ORTHOPAEDIC WIRE?

COLBALT ALLOY ORTHOPAEDIC WIRE is a medical device that received FDA 510(k) clearance on 1981-06-18. The listed applicant is Osteonics Corp.. The 510(k) number is K811500.

When did COLBALT ALLOY ORTHOPAEDIC WIRE receive FDA 510(k) clearance?

COLBALT ALLOY ORTHOPAEDIC WIRE received FDA 510(k) clearance on 1981-06-18, under 510(k) number K811500.

Who is the listed applicant for COLBALT ALLOY ORTHOPAEDIC WIRE?

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

What is the FDA product code for COLBALT ALLOY ORTHOPAEDIC WIRE?

The FDA product code for COLBALT ALLOY ORTHOPAEDIC WIRE is JDR.

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Other records listing Osteonics Corp. as applicant

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K983657OSTEONICS SERIES 7000 AD TIBIAL TRAYK980070OSTEONICS HA-COATED DEVICESK984375OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLYK982798OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEMK984585OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVEK990203OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS

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Related Devices (Code: JDR)

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.

K262451Arthrex DynaNite StaplesArthrex, Inc.K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical Concepts

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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