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FDA 510(k)

PECTOFIX STERNAL REPAIR WIRE

K-Number: K003951 · 2001-03-21

ApplicantPectofix, Inc.
Decision Date2001-03-21
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PECTOFIX STERNAL REPAIR WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Pectofix, Inc.. It received FDA 510(k) clearance on 2001-03-21 under 510(k) number K003951. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PECTOFIX STERNAL REPAIR WIRE?

PECTOFIX STERNAL REPAIR WIRE is a medical device that received FDA 510(k) clearance on 2001-03-21. The listed applicant is Pectofix, Inc.. The 510(k) number is K003951.

When did PECTOFIX STERNAL REPAIR WIRE receive FDA 510(k) clearance?

PECTOFIX STERNAL REPAIR WIRE received FDA 510(k) clearance on 2001-03-21, under 510(k) number K003951.

Who is the listed applicant for PECTOFIX STERNAL REPAIR WIRE?

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

What is the FDA product code for PECTOFIX STERNAL REPAIR WIRE?

The FDA product code for PECTOFIX STERNAL REPAIR WIRE is JDQ.

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 Pectofix, 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.

K000694PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF)

Related Devices (Code: JDQ)

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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