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FDA 510(k)

SYNTHES STERNAL ZIPFIX SYSTEM

K-Number: K110789 · 2011-07-28

ApplicantSynthes (Usa)
Decision Date2011-07-28
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES STERNAL ZIPFIX SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 2011-07-28 under 510(k) number K110789. 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 SYNTHES STERNAL ZIPFIX SYSTEM?

SYNTHES STERNAL ZIPFIX SYSTEM is a medical device that received FDA 510(k) clearance on 2011-07-28. The listed applicant is Synthes (Usa). The 510(k) number is K110789.

When did SYNTHES STERNAL ZIPFIX SYSTEM receive FDA 510(k) clearance?

SYNTHES STERNAL ZIPFIX SYSTEM received FDA 510(k) clearance on 2011-07-28, under 510(k) number K110789.

Who is the listed applicant for SYNTHES STERNAL ZIPFIX SYSTEM?

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

What is the FDA product code for SYNTHES STERNAL ZIPFIX SYSTEM?

The FDA product code for SYNTHES STERNAL ZIPFIX SYSTEM is JDQ.

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Other records listing Synthes (Usa) 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.

K121601SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATEK120854SYNTHES VA LCP ANKLE TRAUMA SYSTEMK120717SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)K120070SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEMK120083SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)K111667SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS

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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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