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FDA 510(k)

SYNTHES SYNEX SPACER SYSTEM

K-Number: K003836 · 2001-05-29

ApplicantSynthes
Decision Date2001-05-29
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES SYNEX SPACER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Synthes. It received FDA 510(k) clearance on 2001-05-29 under 510(k) number K003836. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTHES SYNEX SPACER SYSTEM?

SYNTHES SYNEX SPACER SYSTEM is a medical device that received FDA 510(k) clearance on 2001-05-29. The listed applicant is Synthes. The 510(k) number is K003836.

When did SYNTHES SYNEX SPACER SYSTEM receive FDA 510(k) clearance?

SYNTHES SYNEX SPACER SYSTEM received FDA 510(k) clearance on 2001-05-29, under 510(k) number K003836.

Who is the listed applicant for SYNTHES SYNEX SPACER 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 SYNTHES SYNEX SPACER SYSTEM?

The FDA product code for SYNTHES SYNEX SPACER SYSTEM is MQP.

Related Clinical Trials

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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 DEVICESK110604VBB SYSTEMK093772SYNTHES STERNAL FIXATION SYSTEMK013072CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)

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Related Devices (Code: MQP)

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.

K261810Vertiwedge® Intraosseous SystemFoundation Surgical GroupK261031POSEIDON STSignus Medinzintechnik GmbHK253158VyBrate™ VBR SystemVy Spine, LLCK241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AGK233359DOMINION Expandable Corpectomy SystemAstura Medical

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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