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FDA 510(k)

DISPOSABLE INTRA-ARTICULAR BLADE

K-Number: K830434 · 1983-04-12

ApplicantConcept, Inc.
Decision Date1983-04-12
Product CodeGFA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE INTRA-ARTICULAR BLADE is the device name listed in this FDA 510(k) record. The listed applicant is Concept, Inc.. It received FDA 510(k) clearance on 1983-04-12 under 510(k) number K830434. The device is classified under product code GFA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE INTRA-ARTICULAR BLADE?

DISPOSABLE INTRA-ARTICULAR BLADE is a medical device that received FDA 510(k) clearance on 1983-04-12. The listed applicant is Concept, Inc.. The 510(k) number is K830434.

When did DISPOSABLE INTRA-ARTICULAR BLADE receive FDA 510(k) clearance?

DISPOSABLE INTRA-ARTICULAR BLADE received FDA 510(k) clearance on 1983-04-12, under 510(k) number K830434.

Who is the listed applicant for DISPOSABLE INTRA-ARTICULAR BLADE?

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

What is the FDA product code for DISPOSABLE INTRA-ARTICULAR BLADE?

The FDA product code for DISPOSABLE INTRA-ARTICULAR BLADE is GFA.

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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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Related Devices (Code: GFA)

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.

K971978GRAFT HARVESTING SAWBLADESWrightmedicaltechnologyincK954483STRYKER SAGITTAL SAW ATTACHMENTStryker InstrumentsK955229WRIGHT MEDICAL TECHNOLOGY SAWBLADESWrightmedicaltechnologyincK953012DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLSBoston Surgical Products, Inc.K950403SURGICAL SAW BLADESTransidyne General Corp.K940501RE-SHARPENABLE SAW BLADESAdven Medical

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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