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FDA 510(k)

MENISCAL REPAIR SYSTEM

K-Number: K853829 · 1985-10-08

ApplicantConcept, Inc.
Decision Date1985-10-08
Product Code
DecisionSubstantially Equivalent

Device Summary

MENISCAL REPAIR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Concept, Inc.. It received FDA 510(k) clearance on 1985-10-08 under 510(k) number K853829. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MENISCAL REPAIR SYSTEM?

MENISCAL REPAIR SYSTEM is a medical device that received FDA 510(k) clearance on 1985-10-08. The listed applicant is Concept, Inc.. The 510(k) number is K853829.

When did MENISCAL REPAIR SYSTEM receive FDA 510(k) clearance?

MENISCAL REPAIR SYSTEM received FDA 510(k) clearance on 1985-10-08, under 510(k) number K853829.

Who is the listed applicant for MENISCAL REPAIR SYSTEM?

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

Related Clinical Trials

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.

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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

View all 83 devices →

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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