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FDA 510(k)

INTRA-ARC DISPOSABLE ARTHROPLASTY BURRS

K-Number: K850645 · 1985-03-06

ApplicantConcept, Inc.
Decision Date1985-03-06
Product Code
DecisionSubstantially Equivalent

Device Summary

INTRA-ARC DISPOSABLE ARTHROPLASTY BURRS is the device name listed in this FDA 510(k) record. The listed applicant is Concept, Inc.. It received FDA 510(k) clearance on 1985-03-06 under 510(k) number K850645. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRA-ARC DISPOSABLE ARTHROPLASTY BURRS?

INTRA-ARC DISPOSABLE ARTHROPLASTY BURRS is a medical device that received FDA 510(k) clearance on 1985-03-06. The listed applicant is Concept, Inc.. The 510(k) number is K850645.

When did INTRA-ARC DISPOSABLE ARTHROPLASTY BURRS receive FDA 510(k) clearance?

INTRA-ARC DISPOSABLE ARTHROPLASTY BURRS received FDA 510(k) clearance on 1985-03-06, under 510(k) number K850645.

Who is the listed applicant for INTRA-ARC DISPOSABLE ARTHROPLASTY BURRS?

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

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Other records listing Concept, 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.

K912640CONCEPT ENDOSTEAL FIXATION DEVICEK912957CONCEPT MICROMILLK896648CONCEPT UNICOMPARTMENTAL KNEE SYSTEMK894929STAPLE FIXATION SYSTEMK892376INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)K891109PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE

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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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