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FDA 510(k)

J-FX CERCLAGE SYSTEM

K-Number: K971682 · 1997-06-27

ApplicantJohnson & Johnson Professionals, Inc.
Decision Date1997-06-27
Product CodeLRN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

J-FX CERCLAGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Professionals, Inc.. It received FDA 510(k) clearance on 1997-06-27 under 510(k) number K971682. The device is classified under product code LRN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the J-FX CERCLAGE SYSTEM?

J-FX CERCLAGE SYSTEM is a medical device that received FDA 510(k) clearance on 1997-06-27. The listed applicant is Johnson & Johnson Professionals, Inc.. The 510(k) number is K971682.

When did J-FX CERCLAGE SYSTEM receive FDA 510(k) clearance?

J-FX CERCLAGE SYSTEM received FDA 510(k) clearance on 1997-06-27, under 510(k) number K971682.

Who is the listed applicant for J-FX CERCLAGE SYSTEM?

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

What is the FDA product code for J-FX CERCLAGE SYSTEM?

The FDA product code for J-FX CERCLAGE SYSTEM is LRN.

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Other records listing Johnson & Johnson Professionals, Inc. as applicant

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Related Devices (Code: LRN)

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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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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