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FDA 510(k)

VBB SYSTEM

K-Number: K110604 · 2011-12-13

ApplicantSynthes
Decision Date2011-12-13
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VBB SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Synthes. It received FDA 510(k) clearance on 2011-12-13 under 510(k) number K110604. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VBB SYSTEM?

VBB SYSTEM is a medical device that received FDA 510(k) clearance on 2011-12-13. The listed applicant is Synthes. The 510(k) number is K110604.

When did VBB SYSTEM receive FDA 510(k) clearance?

VBB SYSTEM received FDA 510(k) clearance on 2011-12-13, under 510(k) number K110604.

Who is the listed applicant for VBB SYSTEM?

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

What is the FDA product code for VBB SYSTEM?

The FDA product code for VBB SYSTEM is NDN.

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Other records listing Synthes 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.

K123723SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEMK122455SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEMK113071SYNTHECEL DURA REPLACEMENT DEVICESK093772SYNTHES STERNAL FIXATION SYSTEMK013072CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)K020602SYNTHES PILON PLATE

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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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