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FDA 510(k)

MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM

K-Number: K013527 · 2001-12-21

ApplicantSynthes (Usa)
Decision Date2001-12-21
Product CodeHTO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) 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 2001-12-21 under 510(k) number K013527. The device is classified under product code HTO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM?

MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM is a medical device that received FDA 510(k) clearance on 2001-12-21. The listed applicant is Synthes (Usa). The 510(k) number is K013527.

When did MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM received FDA 510(k) clearance on 2001-12-21, under 510(k) number K013527.

Who is the listed applicant for MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) 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 MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM?

The FDA product code for MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM is HTO.

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Other records listing Synthes (Usa) as applicant

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Related Devices (Code: HTO)

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.

K111437SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)Synthes (USA) Products, LLCK042899SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONSSynthes (Usa)K993335SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEMSynthes (Usa)K954915FLEXIBLE INTRAMEDULLARY REAMERZimmer, Inc.K903248COMBINATION REAMEROnyx Medical Corp.K885100MCCONNELL REAMER GUIDEMcconnell Orthopedic

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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