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FDA 510(k)

COMBINATION REAMER

K-Number: K903248 · 1990-07-30

ApplicantOnyx Medical Corp.
Decision Date1990-07-30
Product CodeHTO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COMBINATION REAMER is the device name listed in this FDA 510(k) record. The listed applicant is Onyx Medical Corp.. It received FDA 510(k) clearance on 1990-07-30 under 510(k) number K903248. 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 COMBINATION REAMER?

COMBINATION REAMER is a medical device that received FDA 510(k) clearance on 1990-07-30. The listed applicant is Onyx Medical Corp.. The 510(k) number is K903248.

When did COMBINATION REAMER receive FDA 510(k) clearance?

COMBINATION REAMER received FDA 510(k) clearance on 1990-07-30, under 510(k) number K903248.

Who is the listed applicant for COMBINATION REAMER?

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

What is the FDA product code for COMBINATION REAMER?

The FDA product code for COMBINATION REAMER is HTO.

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Other records listing Onyx Medical Corp. 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.

K942022FACE-IT SHIELDK931690SPOON PLATEK934614MINI FRAGMENT PLATEK931692T-PLATEK931680CANNULATED CANCELLOUS SCREWK931684EPIPHYSIS PLATE

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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)K013527MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEMSynthes (Usa)K993335SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEMSynthes (Usa)K954915FLEXIBLE INTRAMEDULLARY REAMERZimmer, Inc.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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